Systems and methods for managing information relating to medical fluids and containers therefor

ABSTRACT

The present invention relates to management of information relating to medical fluids, containers therefore, and medical fluid administration devices for administering such medical fluids to patients. Data tags (e.g., RFID tags) are generally associated with containers of the invention and may be electromagnetically read from and/or written to using an electromagnetic device, for example, that may be associated with a medical fluid administration device of the invention.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation in part of previously filed PCTApplication PCT/US2006/012620, filed Apr. 4, 2006, entitled SYSTEMS ANDMETHODS FOR MANAGING INFORMATION RELATING TO MEDICAL FLUIDS ANDCONTAINERS THEREFORE, the entire content of which is hereby incorporatedby reference, which claims the benefit of the following U.S. ProvisionalApplications that are hereby incorporated in their entireties byreference herein:

U.S. Provisional Application Ser. No. 60/668,647, filed 6 Apr. 2005 andentitled SYSTEM AND METHOD FOR TRACKING INFORMATION RELATING TO APHARMACEUTICAL CONTAINER AND/OR PHARMACEUTICAL DISPOSED THEREIN;

U.S. Provisional Application Ser. No. 60/716,166, filed 12 Sep. 2005 andentitled SYSTEM AND METHOD OF TRACKING INFORMATION RELATING TO APHARMACEUTICAL CONTAINER IN A CT SCANNING SUITE;

U.S. Provisional Application Ser. No. 60/668,681, filed 6 Apr. 2005 andentitled APPARATUS AND METHOD FOR LABELING RADIOPHARMACEUTICALS;

U.S. Provisional Application Ser. No. 60/681,252, filed 16 May 2005 andentitled APPARATUS AND METHOD FOR LABELING RADIOPHARMACEUTICALS; and

U.S. Provisional Application Ser. No. 60/718,545, filed 19 Sep. 2005 andentitled ANTENNA SYSTEM AND METHOD OF READING A DATA TAG ON A CONTRASTMEDIA CONTAINER.

FIELD OF THE INVENTION

The present invention relates generally to medical fluids (e.g.,radiopharmaceuticals, contrast media) and, more particularly, totracking and/or managing information relating to medical fluids,containers therefore, and/or medical fluid administration devices usedto administer such medical fluids.

BACKGROUND

Proper administration of pharmaceuticals (e.g., contrast media,radiopharmaceuticals) is dependent on human reliability to insure thecorrect drug is administered properly. In the case of injectablepharmaceuticals, the consequences of mistakes can be severe.Statistically the accuracy of the health care system in providingcorrect injections is excellent. However, with millions of injectionsper year, there is a continuing effort to further reduce mistakes, agreat majority of which are the result of human error.

Of particular interest is the packaging, distribution and use ofcontrast media or a contrast agent. As used herein, a contrast media oragent is a substance that is introduced into, on, or around aphysiological structure (e.g., tissue, vasculature, cell); and becauseof the differences in absorption by the contrast media and thesurrounding tissues, the contrast media allows a radiographicvisualization of the structure. Contrast media is used in x-ray computedtomography (CT), magnetic resonance imaging (MR), ultrasound imaging,angiographic imaging, and other procedures. Often, a container, forexample, a syringe, is filled with a desired quantity of the contrastmedia by an independent supplier; and the filled syringes of contrastmedia are sold or otherwise provided to a hospital, imaging serviceprovider or other health care facility.

Over the useful life of the contrast media and its associated syringe,there are three principal areas of interest for tracking purposes: 1)the location where the contrast media is packaged in a container (e.g.,a syringe); 2) the distribution and storage of the filled syringe; and3) the use and disposal of the syringe. The filling of a syringe withcontrast media can occur at a supplier's facility separate from a healthcare facility; or in some circumstances, within a pharmacy of the healthcare facility. Contrast media comes in many types and concentrations andcan be filled in syringes of different sizes that also vary with thetype of injector to be used. Further, the contrast media has a limitedshelf life and a more limited life when open to atmosphere or whenheated in preparation for injection. Thus, in order to properly fill asyringe with contrast media, knowledge of the contrast media's use, theinjector and sometimes an identity of a patient are required. Inaddition, proper use of the contrast media requires knowledge of its ageand other information relating to when the syringe was filled.

Currently, all this information is manually collected by pharmacists andX-ray technologists. The information pertaining to the syringes can belocated on the syringe package and the syringe label, while informationregarding the contrast concentration, volume, lot number, and expirationdata is generally recorded in the patient's record. The technologistthen uses this information, from multiple sources, to manually set upthe injection; and currently, this information must be manuallytransposed onto various records. Known systems for managingpharmaceuticals provide filled syringes with bar codes having SKUs andother indicia relating to various filled sizes and concentrations ofcontrast media. But this system is limited in use and does not providean efficient management of all of the parameters needed in a medicalenvironment and particularly in connection with the use of contrastmedia. There is a need for a more automated system for enteringinformation relating to contrast media upon filling a syringe. There isa further need to automatically track a particular syringe through adistribution system whether from a supplier external to a health carefacility and/or from a pharmacy within the facility.

A typical X-ray department has an X-ray contrast warming device or box.This device is used to raise the temperature of the contrast media tobody temperature before it is manually injected or installed in aninjector. Additionally, it is considered normal for X-ray departments tostore more than the day's requirement of contrast media in the warmerbox. This creates a complex situation for an X-ray technologistresponsible for manually keeping track of sometimes dozens of contrastmedia syringes. The syringes have to be tracked by quantity, type andtime in the warmer box; and the contrast media syringes should be usedon a first-in first-out basis. As a result, a situation may result wherethere is too much of one type or not enough of another type. This manualtracking of contrast media syringes may also result in some syringesstavina in the warmer box too long, and others being mistakenly removedbefore they have been properly warmed. Therefore, there is a need for amore automated system for tracking contrast media syringes in a warmerbox.

Power injectors are frequently used to inject X-ray contrast media intopatients receiving X-ray imaging procedures. X-ray technologists mayencounter distractions in the course of executing an X-ray procedurethus leading to the possibility of injecting a patient using an emptysyringe. An empty syringe injection often occurs when a technologistretracts a plunger of a syringe with the power injector after aninjection but inadvertently does not replace the empty syringe with anew full syringe—when the next patient is prepared for imaging thetechnologist fails to recognize the empty syringe loaded in the powerinjector because the fully retracted empty syringe looks like a fullsyringe with contrast media. To reduce the risk of using an emptysyringe, power injectors often prompt the technologist with a messageasking the technologist to confirm that air has been purged out of thesyringe and tubing. However, a technologist may answer “yes” to theprompt without carefully checking the syringe and tubing with the resultthat air is injected into a patient. Therefore, there is a need for amore automated system for preventing use of an empty syringe.

It is possible to refill almost any empty syringe with contrast media.Some syringes are intended to be refilled, whereas others are not.However, some engage in a practice of refilling syringes that are notintended to be refilled and/or refill a syringe improperly with a riskof trapping air within the syringe. Therefore, there is a need for anautomated system for tracking the use of a syringe and preventing itssubsequent unauthorized re-use.

The installed base of power injectors in the world is very large due totheir reliability and long useful life. Throughout the life of a powerinjector, the diameter and length of syringes used in that injector mayvary due to tooling, material or process changes over time, or evennormal variations from batch-to-batch. Known power injectors have fixedprogramming for syringe sizes and are not setup to automatically makeadjustments for minor variations in the diameter and length of asyringe. By assuming a diameter and length for a syringe, the volumedelivery accuracy of a power injector is limited. For example,variations in syringe size result in a typical volume accuracyspecification for a power injector of about ±2 milliliters (“ml”) perinjection, even though the electronics and mechanical transmission arecapable of much better. Therefore, there is a need for an automatedsystem for determining variations in syringe size, so that better volumedelivery accuracy can be achieved.

When a power injector fails to operate correctly, a service engineermust be called. In analyzing a power injector experiencing operatingproblems, the injector is operated in a “service” mode, which is oftenachieved by installing electrical jumpers in an injector control. Theservice mode makes testing and troubleshooting the power injectoreasier, but the service mode often disables some safety features of theinjector. Use of a jumper is simple technology; and it is relativelyeasy for a customer to invoke service mode without authorization, forexample, to avoid the inconvenience of various safety checks when usingthe injector. Furthermore, service mode may also be accidentally leftenabled. Since a jumper is located on rear connection panels, it is notreadily visible; and it is possible for the jumper to be mistakenly leftin the power injector, in which case the injector is left in servicemode. If the service mode is used for a medical procedure, eitherdeliberately or mistakenly, the injector may not perform in a safemanner. Therefore, there is a need for a better system for placing apower injector in a service mode and preventing normal use of the powerinjector while it is in the service mode.

Sometimes, when a power injector is not operating properly, the improperoperation cannot be repeated, is intermittent or just cannot be solvedby the service engineer. In such cases the power injector is temporarilyreplaced and returned to the factory for a more thorough examination.Upon the power injector being returned, factory personnel sometimes donot receive sufficient information about the power injector's defectiveoperation to effectively resolve the problem. Therefore, there is a needfor a better system of communicating defective operating conditions tofactory personnel for service purposes.

Often power injector manufacturers embed all possible features into theinjector's software, even though some customers do not want particularfeatures. Manufacturers do this to reduce the development cost and thecomplexity of installations. However, when the manufacturer has a veryhigh value feature, the manufacturer must find a cost-effective andreliable method of activating that feature for only those customers whohave paid for it. Therefore, there is a need for a better system thatpermits a manufacturer to embed all operating features but automaticallyactivate only those features that a particular customer has purchased.

There is also a need for an automated system that tracks syringes fromthe time they are filled with a contrast media, through theirdistribution to a health care facility and/or an imaging suite, throughthe injection of the contrast media from the syringe and then thedisposal or authorized refilling of the syringe. There is a further needfor such an automated system to communicate information regarding theinjection of contrast media to patient records.

Similar problems and needs also exist with respect to the manufacture,storage and use of other pharmaceuticals such as radioactivepharmaceuticals or radiopharmaceuticals. Radiopharmaceuticals, are oftenprepared at a radiopharmacy in which a syringe or vial may be filledwith a desired quantity of the radiopharmaceutical. The syringe or vialmay then be placed into a container called a “pig” that generallyincludes lead and/or other radiation shielding material to protecthandlers from exposure to radiation from the radiopharmaceutical. Afterdelivery, the pig may be opened; the syringe or vial may be removed; andthe radiopharmaceutical may be administered to a patient. The usedsyringe or vial may then be put back in the pig, and pig and syringe orvial may be returned to the radiopharmacy for disposal of the syringeand reuse or disposal of the pig. For purposes of this document, theterm “container” means a structure for holding a radiopharmaceutical andfrom which the radiopharmaceutical may be dispensed, for example, asyringe, vial, etc.

Some radiopharmacies have nuclear medicine tracking systems that use barcode readers to read bar codes on prescription labels to facilitateshipment and receipt of the radiopharmaceutical pig and syringe or vial.Therefore, a person in a receiving nuclear medicine department can scanthe prescription label on the pig to enter data into a procedural datasystem. While this known use of bar codes has improved the reliabilityof passing prescription information through a distribution channel, barcodes have a significant disadvantage. Bar codes store only a limitedamount of information, are “read only” devices and therefore, do notpermit coded information to be changed or updated or new data to beadded to the prescription labels. Further, a bar code must be in a “lineof sight” of a reader to be useful.

While a syringe or vial may be disposed of after use, theradiopharmaceutical pig is cleaned and reconditioned for reuse.Therefore, instead of using adhesives to attach a pharmaceutical labelto a pig, it is known to attach the label to the pig with elastic bands,resilient clear plastic sleeves, etc. While such techniques make a pigeasier to clean for reuse, they do have a disadvantage in that reliablymaintaining a label and pig together may require substantial humaneffort in initially applying the label and then checking and doublechecking the correctness of the label and pig combination over the lifeof the prescription.

The proper handling and use of radiopharmaceuticals may be said torequire highly disciplined processes—and while the occurrence ofmistakes is statistically small, errors still occur in the handling anddelivery of radiopharmaceuticals. Thus, there is a need to provide aprescription label for a radiopharmaceutical that addresses thedisadvantages described above.

SUMMARY

The present invention is generally directed to managing informationrelating to a medical fluid, a container therefore, and/or a medicalfluid administration device. Containers of the invention typically havea data tag associated therewith to enable information to be read fromand/or written to the data tag of the container. This allows informationregarding the container and/or the medical fluid associated therewith tobe ascertained, and optionally updated, for example, during and/orbetween various stages of manufacture, transport, storage, use, and/ordisposal.

As used herein, a “medical fluid” generally refers to a fluid that isdesigned to be administered (e.g., intravenously) to a medical patientas a part of a medical procedure (e.g., diagnostic procedure,therapeutic procedure). Examples of medical fluids include, but are notlimited to, contrast media, radiopharmaceuticals, and saline. A“container” of the invention generally refers to any container designedto have a medical fluid disposed therein. Examples of containers of theinvention include, but are not limited to, syringes, IV bags, and bulkcontrast media containers. An “administration device” of the inventionrefers to any electronic device designed to at least assist intransferring medical fluid from a container to a patient. Examples ofmedical fluid administration devices of the invention include, but arenot limited to, infusion pumps and power injectors.

A first aspect of the invention is directed to a syringe having amedical fluid disposed therein. The syringe includes a data tag forstoring data, such as data relating to a software update for a poweredfluid injector, a product promotion, and/or an electronic coupon codefor sales of further products. Incidentally, a “data tag” herein refersto any device capable of having data electromagnetically read therefromand/or written thereto (e.g., RFID tag).

A second aspect of the invention is directed to a medical fluidadministration device capable of at least assisting in delivering amedical fluid from a container to a patient in a medical procedure. Thecontainer includes a data tag for storing data, and the administrationdevice includes an electromagnetic device. Herein, an “electromagneticdevice” refers to any device capable of electromagnetically reading datafrom and/or writing data to a data tag. The data read from the data tagmay relate to configuration information for the administration device, asoftware update for the administration device, a product promotion,and/or an electronic coupon code for purchases of further products. Inthe case of the data tag including data relating to configurationinformation, and upon the data being read from the data tag by theelectromagnetic device, the configuration information may be used by theadministration device to execute a self-configuration cycle.

A third aspect of the invention is directed to a system for use inassociation with a medical fluid administration device. The systemincludes a service data tag (e.g., as a component of a badge or card)that may be used by service personnel, and an electromagnetic deviceassociated with the administration device. This electromagnetic deviceis operable to read data from and/or write data to the service data tag(e.g., to provide data relating to an identity of the service personand/or configuration information for that particular administrationdevice).

With regard to this third aspect of the invention, the administrationdevice of some embodiments may enable a service mode upon theelectromagnetic device detecting data from the service data tag. In someembodiments, the electromagnetic device may write data to the servicedata tag that relates to service activity information, administrationdevice configuration information and/or administration device useinformation (e.g., fluid administration protocol statistics, containeridentifications, medical fluid use information).

A fourth aspect of the invention is directed to a warmer for warming acontainer having a medical fluid disposed therein. The container has adata tag for storing data associated therewith. The warmer includes botha heating element for elevating the temperature of the medical fluid andan electromagnetic device operable to read data from and/or write datato the data tag associated with the container. The data tag may containdata (which may be read by the electromagnetic device) relating to theamount of medical fluid in the container, the concentration of themedical fluid, manufacturing information regarding the medical fluidand/or the container, the container capacity, the container dimensions,a use code for the medical fluid, and configuration information for amedical fluid administration device to be used in administering themedical fluid to a patient.

With regard to this fourth aspect of the invention, some embodiments mayinclude a user interface (e.g., touch screen) for facilitating userselection of a container in the warmer. In some embodiments, theelectromagnetic device may be used to write data relating to use of themedical fluid to the data tag. For example, the electromagnetic devicemay be used to write data to (and/or read data from) the data tag thatrelates to a date the container was placed in the warmer, an expirationdate for contrast media in the container, and/or administrationinformation for an administration device to be used in administering themedical fluid in the container.

Still a fifth aspect of the invention is directed to a container havinga medical fluid disposed therein and a data tag associated therewith. Inthe case that the medical fluid is a radiopharmaceutical, the data onthe data tag of some embodiments may relate to an identity of theradiopharmaceutical, a radioactivity level of the radiopharmaceutical,manufacturing information for the radiopharmaceutical, a use code forthe radiopharmaceutical (e.g., identifying whether a radiopharmaceuticalcontainer has previously been used in a radiopharmaceuticaladministration procedure), and/or configuration information for anadministration device to be utilized in administering theradiopharmaceutical (e.g., a code that is required by the administrationdevice prior to use of the container, a software update for theadministration device, a product promotion, references to information).

Yet a sixth aspect of the invention is directed to a radiopharmaceuticaladministration device for use in administering a radiopharmaceutical toa patient. This administration device is designed to at least assist indelivering a radiopharmaceutical from a container to a patient. Thecontainer has a data tag associated therewith, and the administrationdevice includes an electromagnetic device for reading data from and/orwriting data to the data tag. In some embodiments, the data included onthe data tag identifies the amount and/or identity ofradiopharmaceutical in the container, manufacturing information for theradiopharmaceutical in the container, the radioactivity level of theradiopharmaceutical in the container, a use code for theradiopharmaceutical in the container, configuration information for theadministration device to be used in administering theradiopharmaceutical from the container, and/or particular data regardinga radiopharmaceutical container previously used with the administrationdevice. In some embodiments, the data tag may store data indicative ofconfiguration information for the administration device that includes acode required by the administration device prior to use of theradiopharmaceutical container (e.g., data used by the administrationdevice in self-configuration upon reading of the data tag), a softwareupdate for the administration device, a product promotion, and/orreferences to information. For instance, in some embodiments, theadministration device may utilize an electronic coupon code included inthe data tag in purchases of further products.

A seventh aspect of the invention is directed to a system for use in amedical procedure with respect to a patient. The system includes ahospital information system, a container having a medical fluid disposedtherein, and an administration device for administering the medicalfluid to a patient. Associated with the container is a data tag that isreadable by electromagnetic signals and that stores signals representingproduct promotions, coupons, Internet links of the supplier, and/orrecommended software updates for administration devices with which thecontainer is intended for use. The system also includes anelectromagnetic device for reading data from and/or writing data to thedata tag associated with the container. This electromagnetic device maybe mounted on the administration device and is preferably in electricalcommunication with both the hospital information system and theadministration device (e.g., the control thereof). The administrationdevice may include a display configured to display contents of the datatag to assist the operator in the administration of the medical fluid toa patient.

Still further, the system includes an imaging apparatus (e.g., CTscanner) that includes an imaging control, which is preferably inelectrical communication with the hospital information system, thecontrol of the administration device, and the electromagnetic device.Incidentally, “electrical communication” or the like herein refers toobjects that are directly and/or indirectly connected in a manner suchthat electricity (e.g., data in the form of electronic signals) can beconveyed between them. Data associated with administration (e.g.,injection, infusion) of the medical fluid may be transferred between thehospital information system, the data tag, the control of theadministration device, and the imaging control. Some embodiments of thisseventh aspect may include a printer in electrical communication withthe administration device (e.g., the control thereof).

An eighth aspect of the invention is directed to an administrationdevice for use with a container having medical fluid disposed. In someembodiments, the medical fluid is metallic and/or diamagnetic. Thecontainer has a data tag that is readable by electromagnetic signalsassociated therewith, and the administration device includes anelectromagnetic device adapted to read data from and/or write data tothe data tag. In some embodiments, this electromagnetic device includesfirst and second antenna loops, each of which forms one side of aV-shape and is tuned to a radio frequency. Each of the first and secondantenna loops may include a signal lead and a ground lead.

Still referring to the eighth aspect of the invention, theelectromagnetic device of some embodiments may include first and secondtuning circuits that correspond with the first and second antenna loops.These tuning circuits may each include an input and an output. Theoutput of the first tuning circuit may be connected to the signal leadof the first antenna loop and may function to tune the first antennaloop to a radio frequency. Similarly, the output of the second tuningcircuit may be connected to the signal lead of the second antenna loopand may function to tune the second antenna loop to a radio frequency(e.g., the same radio frequency as the first antenna loop). The secondantenna loop of the electromagnetic device may be nonparallel (e.g.,form an angle of less than 180 degrees) with the first antenna loop.

Some embodiments of this eighth aspect may include additional antennaloops beyond the first and second antenna loops. For instance, someembodiments may include a third antenna loop having both a signal leadand a ground lead, and a third tuning circuit that includes an input andan output. As with the outputs of the first and second tuning circuits,the output of the third tuning circuit may be connected to the signallead of the third antenna loop and may function to tune the thirdantenna loop to a radio frequency (e.g., the same radio frequency as thefirst and/or second antenna loop).

In some embodiments of the eighth aspect of the invention, theadministration device may be utilized to support the container. Forinstance, in some embodiments, the administration device is anelectronic fluid injector, and the electromagnetic device is mounted inassociation with the injector. The administration device may includeboth a first printed circuit board that supports the first antenna loopand the first tuning circuit, and a second printed circuit board thatsupports the second antenna loop and the second tuning circuit. Thefirst printed circuit board may be oriented in any of a number ofappropriate orientations relative to the second circuit board. Forinstance, in some embodiments, the first circuit board forms an angle ofless than about 180 degrees with the second printed circuit board. Thefirst printed circuit board may support a driver circuit electricallyconnectable to the first antenna loop, the second antenna loop, thefirst tuning circuit, and/or the second tuning circuit. This drivercircuit may include a power terminal and a ground terminal.

In some embodiments of this eighth aspect, the input of the first tuningcircuit is connected to the power terminal, and the ground lead of thefirst antenna loop is connected to the ground terminal. In addition, theinput of the second tuning circuit is not connected to the powerterminal or the ground terminal, and the ground lead of the secondantenna loop is connected to the ground terminal.

In other embodiments of the eighth aspect, the input of the first tuningcircuit is not connected to the power terminal or the ground terminal,and the ground lead of the first antenna loop is connected to the groundterminal. In addition, the input of the second tuning circuit isconnected to the power terminal, and the ground lead of the secondantenna loop is connected to the ground terminal.

In still other embodiments of the eighth aspect, the input of the firsttuning circuit is connected to the power terminal, and the ground leadof the first antenna loop is connected to the ground terminal. Inaddition, the input of the second tuning circuit is connected to theground terminal, and the ground lead of the second antenna loop isconnected to the ground terminal.

In yet other embodiments of the eighth aspect, the input of the firsttuning circuit is connected to the ground terminal, and the ground leadof the first antenna loop is connected to the ground terminal. Inaddition, the input of the second tuning circuit is connected to thepower terminal, and the ground lead of the second antenna loop isconnected to the ground terminal.

Some embodiments of the eighth aspect may be equipped with a switchingcircuit including first and second switches. The first switch mayinclude a first contact connected to the input of the first tuningcircuit, a second contact connected to the ground terminal, a thirdcontact connected to the power terminal, and a fourth contact notconnected to the ground terminal or the power terminal. This firstswitch is preferably operable to electrically connect the first contactwith at least one of the second contact, the third contact and thefourth contact. Similarly, the second switch may include a fifth contactconnected to the input of the second tuning circuit, a sixth contactconnected to the ground terminal, a seventh contact connected to thepower terminal, and an eighth contact not connected to the groundterminal or the power terminal. This second switch is preferablyoperable to electrically connect the fifth contact with at least one ofthe sixth contact, the seventh contact and the eighth contact.

In a ninth aspect, the invention is directed to a method of using amedical fluid administration device that includes an electromagneticdevice operable to read data from and/or write data to a data tag. Thisdata tag is associated with a container that has medical fluid disposedtherein. In this method, first and second antenna loops of theelectromagnetic device are electrically connected in a first circuitconfiguration and are tuned to a substantially identical radiofrequency. These first and second antenna loops may be oriented in anonparallel relationship relative to one another. An electromagnetic(e.g., RF) communication may be attempted between the electromagneticdevice and the data tag, at least in part, by providing electromagneticpower to the first circuit configuration. A determination may be made asto whether or not electromagnetic communication is or was establishedbetween the electromagnetic device and the data tag. If it is determinedthat electromagnetic communication is/was not made, the first and secondantenna loops may be electrically reconnected in a further (e.g.,second) circuit configuration different from the first circuitconfiguration. Then, another electromagnetic communication between theelectromagnetic device and the data tag may be attempted, at least inpart, by providing electromagnetic power to the further circuitconfiguration. The process of determining whether or not an electricalcommunication exists, electrically reconnecting the first and secondantenna loops, and attempting another electromagnetic communication maybe repeated as desired (e.g., until determining that a successfulelectromagnetic communication has been established between theelectromagnetic device and the data tag).

A tenth aspect of the invention is directed to a method of using amedical fluid administration device that includes an electromagneticdevice operable to read data from and/or write data to a data tag. Inthis method, a data tag is disposed near an antenna system of theelectromagnetic device, and a material that interferes withelectromagnetic signals (e.g., metallic material, diamagnetic material)is disposed between the data tag and the antenna system. Even though thematerial is disposed between the data tag and the antenna system, datamay still be electromagnetically read from and/or written to the datatag using the electromagnetic device and the antenna system thereof.

In some embodiments of this tenth aspect, the data tag is a component ofa container that has medical fluid (which, in this case, is or includesthe material) disposed therein. In such embodiments, the medical fluidmay be, for example, water, saline, contrast media, or a combinationthereof. In such embodiments, the container may be placed near (e.g., incontact with) the administration device in a manner such that the datatag of the container is located near the antenna system and such thatthe material in the container is located between the data tag and theantenna system. While not always the case, the electromagnetic deviceand the antenna system thereof may be components of the administrationdevice.

Some embodiments of the antenna system of this tenth aspect may includefirst and second antenna loops. In these embodiments, the first andsecond antenna loops may be electrically connected in a first antennaconfiguration, and electromagnetic signals from this first antennaconfiguration may be emitted to at least attempt to electromagneticallyread data from and/or electromagnetically write data to the data tag. Inresponse to a failure to electromagnetically read data from and/orelectromagnetically write data to the data tag when the first and secondantennas are in the first configuration, the first and second antennaloops may be electrically reconnected in another (e.g., second) antennaconfiguration, and electromagnetic signals from the new antennaconfiguration may be emitted to again at least attempt toelectromagnetically read data from and/or electromagnetically write datato the data tag.

In an eleventh aspect, the invention is directed to a container assemblythat includes a medical fluid container that is enclosable inside anenclosure. Associated with the container are both a data tag thatincludes a data store and an antenna system that is electricallyconnectable to the data tag. The construction of the enclosure of thiseleventh aspect is such that a frequency of electromagnetic signalnecessary to read data from and/or write data to the data tag issubstantially prevented from passing through the material of theenclosure. The antenna system of this eleventh aspect is designed sothat an antenna thereof is located outside the enclosure while thecontainer and the data store of the data tag are enclosed in theenclosure. This antenna system permits data to be read from and/orwritten to the data store while the container and the data store of thedata tag are enclosed within the enclosure.

Still a twelfth aspect of the invention is directed to aradiopharmaceutical assembly that includes a radiopharmaceuticalcontainer (e.g., a syringe having a radiopharmaceutical disposedtherein) and a radiopharmaceutical pig that is enclosable about thecontainer to fully surround and support the container. In addition, thistwelfth aspect includes a data tag that includes a data store and thatis attached to the radiopharmaceutical container. An antenna system iselectrically connectable to the data tag upon the radiopharmaceuticalcontainer (and the data tag attached thereto) being placed in theradiopharmaceutical pig. This antenna system permits data to be readfrom and/or written to the data store of the data tag while theradiopharmaceutical pig is closed around the radiopharmaceuticalcontainer and the data tag.

In some embodiments of this twelfth aspect, the radiopharmaceutical pigmay be characterized as having both a first pig component (e.g., a base)adapted to support the radiopharmaceutical container with the data tagand a second pig component (e.g., a cap) that is attachable to the firstpig component and adapted to fully enclose the radiopharmaceuticalcontainer with the data tag within the radiopharmaceutical pig. In suchembodiments, the antenna system may be adapted to be electricallyconnectable to the data tag upon the radiopharmaceutical container beingplaced in the first pig component of the radiopharmaceutical pig. Theantenna system of these embodiments permits data to be read from and/orwritten to the data store of the data tag while the first pig componentis attached to the second pig component and while theradiopharmaceutical container and the data tag are enclosed inside theradiopharmaceutical pig. In some of these embodiments the antenna systemmay be include an antenna electrically connected to the data tag, aninner antenna adjacent an inner surface of one of the first pigcomponent and the second pig component, an outer antenna adjacent anouter surface of one of the first pig component and the second pigcomponent, and a conductive lead electrically connecting the innerantenna with the outer antenna. The antenna of some embodiments of thetwelfth aspect may be attached to (e.g., fixed to) theradiopharmaceutical container.

Still referring to the twelfth aspect of the invention, some embodimentsof the antenna system may be characterized as having an antennalocatable outside the radiopharmaceutical pig, and a conductive leadthat has one end connected to the data tag within theradiopharmaceutical pig and an opposite end connected to the antennalocated outside the radiopharmaceutical pig.

In yet a thirteenth aspect, the invention is directed to a powerinjector capable of supporting a syringe that has a medical fluiddisposed therein. Particularly, the medical fluid is located between aplunger and a discharge tip of the syringe. The syringe includes a datatag for storing data that is electromagnetically readable from the datatag. The injector of this thirteenth aspect includes a powerhead havinga plunger drive adapted to interface with (e.g., be connected to) theplunger of the syringe. An injector control of the injector isoperatively connected to the powerhead. Further, an electromagneticdevice of the injector is mounted on the powerhead and is in electricalcommunication with the injector control. This electromagnetic deviceincludes a plurality of antennas operative to transmit electromagneticsignals to and receive electromagnetic signals from the data tag (e.g.,to read data stored in the data tag).

In some embodiments of this thirteenth aspect, the electromagneticdevice may include a plurality of tuning circuits electrically connectedto respective antennas for tuning the respective antennas to a desiredfrequency(ies). For instance, in some embodiments, the tuning circuitsmay be utilized to tune the respective antennas to a frequency of about13.56 Megahertz. A driver circuit of the electromagnetic device may beelectrically connectable to the tuning circuits and the injectorcontrol. This driver circuit may function to provide drive signals tothe tuning circuits causing the respective antennas to transmitelectromagnetic signals to and receive electromagnetic signals from thedata tag (e.g., to read data stored in the data tag). Some embodimentsmay include a switching circuit electrically connected between thedriver circuit and the tuning circuits. This switching circuit may beutilized to connect the antennas in different circuit configurations. Insome embodiments, at least one of the switching circuit and the drivercircuit are located in the powerhead of the injector.

Still referring to the thirteenth aspect of the invention, someembodiments of the powerhead may include a forward end adapted toreceive and support the syringe. In some embodiments, this forward endmay include or be characterized as a mount of sorts adapted toaccommodate (e.g., receive and support) the syringe. In someembodiments, the mount may include a pressure jacket for supporting thesyringe. In such embodiments, the antennas may be mounted on thepressure jacket. Some embodiments of the mount may not include apressure jacket. Some embodiments of the mount may include what may bereferred to as a cradle to support the syringe. In such embodiments, theantennas may be supported by and/or located within the cradle.

Some embodiments of the thirteenth aspect may have a pressure jacketthat includes an inner sleeve and an outer sleeve disposed about theinner sleeve. One or more antennas may be located between the innersleeve and the outer sleeve of the pressure jacket. For instance, insome embodiments, a plurality of antennas may be disposed between theinner and outer sleeves and equally spaced about a circumference of thepressure jacket. In some embodiments, one or more tuning circuits may belocated between the inner sleeve and the outer sleeve.

Some embodiments of the injector of the thirteen aspect of the inventionmay include a heater (e.g., for heating the medical fluid disposed inthe syringe). For example, in some embodiments, the heater may beattached to or a component of a pressure jacket of the injector. Asanother example, in some embodiments, the heater may be attached to or acomponent of a cradle of the injector. In embodiments equipped with aheater, the heater may be electrically connected to the injectorcontrol.

The syringe employed in this thirteen aspect of the invention mayexhibit any of a number of appropriate structuraldesigns/configurations. For instance, in some embodiments, the plungerof the syringe is substantially wholly contained within a barrel of thesyringe. Further, the syringe employed in this thirteen aspect of theinvention may exhibit any of a number of appropriate sizes (e.g., volumecapacities). As an example, the syringe of some embodiments exhibits avolumetric capacity capable of accommodating a volume of fluid in excessof about 90 ml.

A fourteenth aspect of the invention is directed to a system formanaging data relating to a container and/or a medical fluid disposedtherein. The container includes a data tag operable to have data writtenthereto and read therefrom. A filling station of the system may beutilized to place the medical fluid in the container. This fillingstation includes an electromagnetic device operable to at least writedata (e.g., relating to the fluid in the container) to the data tag.Further, a disposal station of the system may be utilized in disposingof and/or preparing for disposal of the container (which may or may notstill have medical fluid therein). This disposal station also includesan electromagnetic device operable to write data (e.g., relating todisposal of the container) to the data tag. The system may also includea hospital information system in electrical communications with one ormore electromagnetic devices of the system.

In some embodiments of this fourteenth aspect, the system may include awarmer that may be utilized to heat the fluid in the container. Thiswarmer is generally equipped with an electromagnetic device operable towrite data (e.g., relating to placing the container in and/or removingthe container from the warmer) to the data tag.

Some embodiments of the fourteenth aspect may include a medical fluidadministration device. For example, in some embodiments, theadministration device is a power injector for use with a syringe. Thepower injector generally includes both a control and an electromagneticdevice that is electrically connected to the control and operable towrite data (e.g., relating to administration of the medical fluid intothe patient) to the data tag.

In some embodiments, the system of the fourteenth aspect may include apackaging station that may be used in placement of the container into apackage. This packaging station may include an electromagnetic deviceoperable to write data (e.g., relating to the package, the fluid and/orthe container) to the data tag.

Some embodiments of the system may include a storage area for storingthe container (which may or may not already have the medical fluiddisposed therein). This storage area generally includes anelectromagnetic device operable to write data (e.g., relating to placingthe syringe in and/or removing the syringe from the storage area) to thedata tag.

In some embodiments of the fourteenth aspect, the medical fluid that isin or is to be placed in the container is a radiopharmaceutical. In suchembodiments, a packaging station (e.g., radiopharmacy) of the system maybe used during placement of the container into a radiopharmaceuticalpig. Further, the packaging station may be utilized when placing theradiopharmaceutical pig in a package (e.g., a transport package). Thispackaging station may include an electromagnetic device operable towrite data (e.g., relating to the radiopharmaceutical, the container,the pig, and/or the package) to the data tag.

Some embodiments of the system may include a calibration station thatincludes an electromagnetic device operable to write data (e.g.,relating to radioactivity level of the radiopharmaceutical in thecontainer) to the data tag. Some embodiments of the system may include atreatment room where the radiopharmaceutical pig may be received and thecontainer having the radiopharmaceutical disposed therein is removed foradministration of the radiopharmaceutical to a patient. This treatmentroom may include an electromagnetic device operable to write data (e.g.,relating to administration of the radiopharmaceutical to the patient) tothe data tag. A storage area of the system may include anelectromagnetic device operable to write data (e.g., relating to placingthe pig into and/or removing the pig from the storage area) to the datatag.

In a fifteenth aspect, the invention is directed to a medical fluidinjection system that has a contrast media container with an RF data tagand a powerhead for delivering the contrast media from the container.The powerhead has an electromagnetic device operable to read data fromthe RF data tag, and a display operable to display data read from the RFdata tag by the electromagnetic device.

In some embodiments of the fifteenth aspect, the display may be operableas an interactive user interface, and further, may be operable todisplay data indicative of a presence of at least one of the containerand the RF data tag on the container. The display may also be operableto display the data in response to user interaction with the display. Inother embodiments, the electromagnetic device may be operable to writedata to the RF data tag; and in further embodiments, the display may beoperable to display the data read from the RF data tag overlaying otherdata displayed on the display. In still further embodiments, the displaymay be operable to display data indicative of an amount of the contrastmedia in the container, an identity of the contrast media in thecontainer, manufacturing information for the contrast media in thecontainer, a radioactivity level of a contrast media in the container, ause code for the contrast media in the container, configurationinformation for the injection system, whether or not the container waspreviously used with this or another injection system, a lot number ofthe contrast media in the container, and/or an expiration date of thecontrast media in the container.

In still further embodiments of the fifteenth aspect, a medical fluidinjection system is operated by coupling a contrast media container witha powerhead of the medical fluid injection system. Data from an RF datatag on the container is read, and at least some of the data read fromthe RF data tag is displayed on a display of the powerhead. In otherembodiments, operating the display as a user interface, the powerhead isoperable to cause a representation of the container to be displayed, theRF data tag to be interrogated, and in response to finding the RF datatag, indicating a presence of the RF data tag on the representation ofthe container on the display. In still further embodiments, thepowerhead is operable to write data to the RF data tag while thecontainer is coupled with the powerhead and to cause data read from theRF data tag to be overlayed over other data displayed on the display.

Various refinements exist of the features noted in relation to theabove-mentioned aspects of the present invention. Further features mayalso be incorporated in the above-mentioned aspects of the presentinvention as well. These refinements and additional features may existindividually or in any combination. For instance, various featuresdiscussed below in relation to any of the exemplary embodiments of thepresent invention may be incorporated into any of the aspects of thepresent invention alone or in any combination.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying figures, which are incorporated herein and constitute apart of this specification, illustrate exemplary embodiments of theinvention and, together with a general description of aspects of theinvention given above, and the detailed description of various exemplaryembodiments given below, serve to explain various principles of theinvention.

FIG. 1A is a schematic drawing of a system for tracking a syringe filledwith contrast media over a syringe life cycle.

FIG. 1B is a schematic drawing of a system for tracking a containerfilled with a radiopharmaceutical over a container life cycle.

FIG. 1C is a schematic drawing of a system for tracking an IV bag filledwith a medical fluid over an IV bag life cycle.

FIGS. 2A-2D are perspective views of a syringe that illustrate differentmanners of applying a tracking device to a syringe filled with contrastmedia in the system shown in FIG. 1A.

FIG. 3A is a schematic block diagram of components associated with thesystem illustrated in FIG. 1A.

FIG. 3B is a schematic block diagram of components associated with thesystem illustrated in FIG. 1B.

FIG. 3C is a schematic block diagram of components associated with thesystem illustrated in FIG. 1C.

FIG. 4 is a schematic drawing illustrating activities and operationsassociated with use and disposal of a container of contrast media in animaging suite.

5 FIG. 5A is a perspective view of one embodiment of an injector thatmay be used in the system of FIG. 1A.

FIG. 5B is a perspective view of an embodiment of an injector and afield engineer identification card that may be used in the system ofFIG. 1A.

FIG. 5C is a perspective view of the injector of FIG. 5A.

FIG. 5D shows further detail of the contents on the display of theinjector or remote interface in FIG. 5C.

FIG. 6 is a flowchart of an exemplary method of manufacturing anddistributing a syringe or other container as shown in FIGS. 1A and 1B.

FIG. 7 is a flowchart of an exemplary method of stocking and preparingfor use of a syringe or other container as shown in FIGS. 1A and 1B.

FIG. 8 is a flowchart of an exemplary method of using a syringe or othercontainer as shown in FIGS. 1A and 1B.

FIG. 9 is a flowchart of an exemplary method of a field maintenanceprocess for a syringe filled with contrast media as shown in FIG. 1A.

FIG. 10 is a schematic drawing illustrating a variation in RF signalstrength in coupling a transmitting antenna with a receiving antennaangled with respect to the transmitting antenna.

FIG. 11 is perspective view of a contrast media power injector having anRF data tag on a syringe mounted in a power injector.

FIG. 12 is a perspective view of an exemplary embodiment illustrating asyringe positioned above a faceplate of a contrast media power injectorhaving multiple, nonparallel antenna loops for a read/write device inaccordance with the principles of the present invention.

FIGS. 13A-13D are schematic drawings of four different circuitconfigurations for the multiple, nonparallel antenna loops of FIG. 12.

FIG. 14 is a schematic drawing of the multiple, nonparallel antennaloops of FIG. 11 with switches for connecting the antenna loops in thefour different circuit configurations of FIGS. 13A-13D.

FIG. 15 is schematic drawing of a flowchart illustrating acommunications cycle utilizing the multiple, nonparallel antenna loopsof FIG. 12.

FIG. 16 is a cross-sectional drawing of a pressure jacket for a contrastmedia power injector as shown in FIG. 11, which is equipped with amultiple loop, nonparallel antenna system for the contrast media powerinjector similar to that illustrated in FIG. 12.

FIG. 17 is a schematic drawing of an electromagnetic radio frequency R/Wdevice utilizing the multiple loop, nonparallel antenna system of FIG.16.

FIG. 18 illustrates different manners of applying a tracking device to aradiopharmaceutical container and respective pig in the system shown inFIG. 1.

FIG. 19 is a flowchart of an exemplary method of post-processing aradiopharmaceutical container and associated pig.

FIG. 20 is a perspective view of an exemplary embodiment of an RF tagand antenna system that is applicable to a radiopharmaceutical syringeand associated radiopharmaceutical pig in accordance with the principlesof the present invention.

FIG. 21 is a perspective view of another exemplary embodiment of an RFtag and antenna system that is applicable to a radiopharmaceuticalsyringe and associated radiopharmaceutical pig in accordance with theprinciples of the present invention.

FIG. 22 is a perspective view of a further exemplary embodiment of an RFtag and antenna system that is applicable to a radiopharmaceuticalsyringe and associated radiopharmaceutical pig in accordance with theprinciples of the present invention.

FIG. 22A is an exploded view showing a path of an antenna lead in thefurther embodiment of the radiopharmaceutical syringe and associatedradiopharmaceutical pig shown in FIG. 22.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring to FIG. 1A, an exemplary embodiment of a container life cycle18 a relates to medical fluid containers, for example, a syringe 20suitable for storing contrast media. The syringes 20 may be manufacturedat a supplier facility 24 that is remote from a facility 42 in which asyringe 20 is to be used. Within the supplier facility 24, the syringe20 is first filled with a contrast media at a filling station 28, andthereafter, labels 30 may be applied to respective syringes 20 at alabeling station 32. The syringes 20 may then be packaged eithersingularly or as a batch in an appropriate shipping carton 34 at apackaging station and the shipping cartons 34 may be temporarily queuedor stored in a shipping/receiving department 38.

Orders for the syringes 20 can be received from various sources, forexample, a purchasing office 25 within a health care facility 42, or adoctor's office 27 that may be part of, or independent from, the healthcare facility 42. Further, the orders may or may not be associated witha particular patient.

Based on the orders, the shipping cartons 34 may enter a distributionchannel 40 by which they may be delivered to various facilities 42, forexample, hospitals, image service providers, and/or other health carefacilities. In the example of FIG. 1A, the facility 42 is a hospitalthat has a shipping/receiving area 44 for receiving the cartons 34 ofprefilled syringes 20. Incidentally, “prefilled” herein describes acontainer that is designed to be sold and/or delivered to a user with atleast some medical fluid already disposed in the container. Often, thecartons 34 are temporarily stored in a room 46 that may or may not beassociated with a pharmacy within the hospital 42. As desired, thecartons 34 may be transferred to a preparation room 48 at which thesyringes 20 may be unpacked and placed in a warming oven 36 to raise thetemperature of the contrast media up to about body temperature (e.g.,between about 97° F. and about 100° F.). At appropriate times, one ormore syringes 20 may be removed from the warming oven 36, carried to theimaging suite 26 a and loaded into a powered fluid injector 50. Theinjector 50 operates to inject the contrast fluid into an examinationsubject or patient 52. After use, the spent syringe 20 may be processedfor an authorized refilling or disposed of (e.g., in a disposal area112) in a known manner. For purposes herein, the term “prefilledsyringe” means a syringe 20 prefilled with a medical fluid (e.g.,contrast media) at a location remote from the preparation room 48 andimaging suite 26 a.

As with any substance to be injected into an animal, there are a greatmany regulated practices as well as unregulated common practices thatare desirable to be followed in the filling, distribution, preparationand use of a prefilled syringe. Further, the regulated and commonpractices may differ depending on the type of contrast media being used.Consequently, it is generally desirable to generate and provide asubstantial amount of data relating to the handling of the syringe 20throughout its life cycle, for example, at substantially every step fromits filling to its disposal. Further, it is generally preferred that thedata be transferable from one location, for example, the respectivefilling and labeling stations 28, 32, to another location, for example,the respective preparation and imaging rooms 48, 26 a. Today, such datahas been known to be recorded and transferred utilizing typed and/orhand-written information located on the syringes 20 and/or cartons 34 aswell as typed and/or hand-written records associated therewith. However,during the life of a syringe 20, the data is desired to be utilized incomputer systems that may, most often, not be integrated and sometimes,in databases that may not be compatible.

In order to provide a common data acquisition and storage system foreach syringe 20, which can be utilized during any portion, and at everystage, of the container life cycle 18 a, a system of radio frequencyidentification device (“RFID”) tags and readers is used.

The object of an RFID-based system is to carry data in transponders,generally known as tags, and to retrieve data, by machine-readablemeans, at a suitable time and place to satisfy a particular applicationneed. Thus, a tag or transponder may typically include an RF drivercircuit and associated antenna. The RF driver circuit often utilizes anintegrated circuit chip having a programmable processor and associatedmemory, which are capable of storing the data and performing necessarydemodulation and, if applicable, modulation functions. Data within a tagmay provide any manner of information relating to a prefilled syringethat is useful over the life of the syringe. It is generally preferredthat an RFID system include a means for reading data from, and in someapplications, writing data to, the tags, as well as a means forcommunicating the data to a computer or information management system.Thus, an RFID system preferably has the versatility to permit data to bewritten into, and read from, a tag at different times and at differentlocations.

Wireless communication is most often used to transfer data between a tagand a reader. Such communication is often based upon propagatingelectromagnetic waves, for example, radio frequency waves, by antennastructures present in both tags and readers. It is known to use either acommon antenna or different antennas with an RFID tag to read data from,and write data to, the tag; closed loop, open loop, stripline, dipoleand/or other antennas may be used. Further, RFID tags may be passive,that is, without an independent power supply, or active, that is, with apower supply such as a battery. In applications described herein, thechoice of a particular antenna configuration and whether to use anactive or passive RFID tag may or may not be application dependent.

An exemplary embodiment of a syringe manufacturing process implementedat a supplier facility 24 is illustrated in FIG. 6. First, at 502, asyringe 20 is filled with contrast media 22 at a filling station 28.Thereafter, at 504, a label 30 containing human readable and/ormachine-readable indicia is applied to the syringe 20 at the labelingstation 32. As part of the labeling process, an RFID tag 60 is appliedto the syringe 20. The RFID tag 60 incorporates an RFID chip andassociated antenna in a known manner, for example, as shown in FIG. 5Aby the RFID chip 212 and antenna 210; and the RFID tag 60 may be a partof or separate from the label 30. As shown in FIGS. 2A-2D, the RFID tagcan be applied at any suitable location on the syringe 20. For example,as shown in FIG. 2A, the RFID tag 60 can be applied to a rear surface 55of a syringe flange 56; and as shown in FIG. 2B, the RFID tag 60 can beapplied to an outer cylindrical surface 57 of the syringe. In anotherembodiment shown in FIG. 2C, prior to the syringe 20 being loaded into apower head of an injector, the RFID tag 60 can be peeled off of thesyringe 20 and applied to the injector. Upon removing the syringe 20from the injector power head, the RFID tag may be reapplied to thesyringe 20. In a still further embodiment shown in FIG. 2D, the RFID tag60 can be applied to a rear surface 58 of a plunger 59. The plunger 59may have a core 61 covered by a molded material 63, and an RFID tag canbe applied to or integrated into the plunger structure at variouslocations 65 a, 65 b, 65 c, etc. As shown in FIG. 2D, an RFID tag may beapplied as shown at 60′ on the discharge extension (e.g., nozzle)extending from the distal end of the syringe 20, or as shown at 60″, anRFID tag can be applied to a front wall (e.g., tapering front wall) ofthe syringe 20.

Within the supplier facility 24 of FIG. 1A, a read/write (“R/W”) device62 is connected to a labeling computer 64 and, at 506 (FIG. 6), isoperative to write data in the RFID tag 60 relating to contrast media orother pharmaceutical and its associated prefilled syringe or othercontainer 20. Data that can be written to the RFID tag 60 includes, butis not limited to, the following:

-   -   A unique container identification number.    -   A security code that limits access to the RFID tag to those R/W        devices that are able to provide the security code.    -   A volume of the pharmaceutical filled in the container.    -   A total available volume and/or physical dimensions of the        available volume in the container.    -   An identity, or type, of the pharmaceutical in the container.    -   A concentration of the pharmaceutical.    -   A formula of the pharmaceutical.    -   A manufacturing date.    -   An identity of a factory, production line, filling station        machine, and/or batch number associated with the container.    -   A date and time at which the container is filled.    -   An expiration time and/or date and/or a shelf life of the        pharmaceutical.    -   NDC codes.    -   One or more vendor specific inventory codes, for example, an SKU        code.    -   An identity of the country in which the container was filled.    -   An identity of the container and/or container packaging.    -   Product promotions and/or coupons and/or Internet links of the        supplier.    -   Recommended software updates for power injectors in which the        container is intended for use.

Thereafter, at 508, the syringe 20 is loaded into a shipping carton 34;and, at 510, the cartons 34 are stocked as inventory in ashipping/receiving department 38. Based on orders received, as indicatedat 512, the cartons 24 may be further combined or palletized into a caseor batch 67 for shipment to a customer; and a label 66 can be optionallyapplied to an individual shipping carton 34 or a unified case or batch67 of cartons. The label 66 can include human readable, machine-readableindicia and/or be an RFID tag. Such indicia or RFID tag data may includebut is not limited to an identification of the supplier and the product,the product expiration date and the packaging. The packaging codeidentifies whether the package is a single syringe, a carton of syringesor a case of syringes. In preparing one or a batch of cartons 34 forshipment, an R/W device 68 connected to a shipping computer 70 may beused to read data from, and write data to, the RFID tags 60 on thesyringes 20 within the cartons 34. In addition, if applicable, the R/Wdevice 68 may be used to read data from, and write data to, RFID tagsassociated with the labels 66. Thus, the shipping computer 70 is able toidentify parameters, for example, type of syringe, type of contrastmedia, contrast media concentration, etc., and confirm that thoseparameters meet the specifications of a particular order. Thus, the R/Wdevice 68 can be used to write into either the RFID tags 60 on thesyringes 20, and/or the RFID tags on labels 66, data including, but notlimited to, the following:

-   -   An identity of the customer.    -   Purchase invoice and tracking numbers.    -   Purchase and/or shipment dates.    -   Customer specific marketing data.    -   Customer specific software updates for power injectors owned by        the customer.

The cartons 34 then enter the distribution channel 40 and are receivedby a receiving department 44 of an imaging facility such as the hospital42. An example of a syringe stocking and preparation process isillustrated in FIG. 7. Upon receiving the cartons 34, a R/W device 72connected to a shipping/receiving computer 74 reads, at 602, the syringeRFID tags 60 and/or the shipping carton RFID tags 66. As shown in FIG.3A, the shipping/receiving computer 74 stores the read data in aninventory database 76. The shipping/receiving computer 74 is connectedvia a communications link, for example, an Ethernet LAN, etc., to ahospital administration computer 78 and other computers; and one or moreversions of the inventory database 76 can be maintained in any of thosecomputers. Thus, the receiving computer 76, or another computer, is ableto confirm that the delivered syringes conform to hospital purchaseorders and, if applicable, automatically authorize payment of invoicestherefore. Further, via the shipping/receiving computer 74, the syringeRFID tags 60 within the cartons 34 can, at 604, be updated with otherdata including, but not limited to:

-   -   A time and date that the container was received.    -   A hospital SKU code.    -   Doctor related information.    -   Patient related information.    -   An identity of a stock room or other storage area.    -   An identity of a particular preparation room and/or imaging        suite in which the pharmaceutical is to be used.    -   An identity of a particular power injector, which is to be used.

Thereafter, at 606, cartons are delivered to a room 46. As seen in FIGS.3A and 1A, within the room 46, a R/W device 77 connected to a computer79 can be used to read the syringe RFID tags 60 and update a databasewithin the computer 79. Further, or alternatively, as shown in FIG. 3A,the computer 79, via the communications link 80, can be used to updatethe inventory database 76 within administration computer 78, therebyconfirming delivery of the syringes to the room 46 from theshipping/receiving area 44.

The communications link 80 may be implemented by an Ethernet, USB,RS-232, RS-422, or other interface that uses a standard PC-basedcommunications protocol, for example, BLUETOOTH, parallel, IrDA, ZigBee,802.11b/g, or other comparable wired or wireless connection.

Subsequently, instructions are provided to move a shipping carton 34from the room 46 to a preparation room 48. The R/W device 77 is used toread the RFID tags, at 606, and find the cartons 34 containing thedesired syringes. Further, reading the RFID tags permits anidentification of the oldest inventory. (Since contrast media has ashelf life, it may be appropriate to follow a first-in/first-outinventory procedure.) Thereafter, at 608, an identified shipping carton34 is delivered to the preparation room 48.

In the preparation room 48, the syringes 20 are removed from a carton 34and placed in the warmer 36 to bring the contrast media up to about bodytemperature. As shown in FIGS. 1A, 3A and 4, an R/W device 81 isconnected to a warmer control 82 having a user interface 86. The warmercontrol 82 is electrically connected to an imaging information system 87that, in turn, is connected to the communications link 80, and hence, tothe other computers in the hospital 42. Upon placing a syringe in thewarmer 36, the R/W device 81 reads, at 610, a respective RFID tag 60 andtransmits data with respect to the syringe 20 to a work-in-processdatabase 84 in the imaging information system 87 as illustrated in FIG.3A. Further, or alternatively, the imaging information system 87, viathe communications link 80, can be used to update the inventory database76, thereby allowing other computers to track information written to andread from the syringe RFID tags 60 in the warmer 36. RAIN device 81 mayalso write to each RFID tag 60 the time and date each respective syringe20 is placed in the warmer 36. Further, upon a technologist requesting,via the user interface 86, a particular contrast media, the warmercontrol 82 can, via the user interface 86, identify to the technologista particular syringe inside the warmer 36, such as the syringe that hasbeen in the warmer for the longest period of time. (Not only doescontrast media have a limited shelf life, but the time spent in thewarmer 36 should also be limited. Thus, inventory in the warmer 36 mayalso be handled on a first-in/first-out basis.) Upon removing a syringe20 from the warmer, at 612, the R/W device 81 writes the removal timeand date to a respective RFID tag 60 and reads data identifying thesyringe being removed. The work-in-process database 84 and otherdatabases are appropriately updated; and the warmer control 82 via theuser interface 86 confirms to the technologist that the correct syringehas been removed.

Referring to FIGS. 1A, 3A, 4 and 5A, one or more syringes 20 a, 20 b arethen carried into an imaging suite 26 a and loaded into respectively oneor both of the mounts or faceplates 88 a, 88 b that are attachable on apowerhead 90 of a powered fluid injector 50 in a known manner. Anexemplary injector is shown and described in U.S. patent applicationSer. No. 10/964,003, the entirety of which is hereby incorporated byreference. Although the powerhead 90 discussed herein is a dual headinjector, embodiments of the present invention explicitly contemplatesingle head injectors as well. A suitable single-head injector is shownin U.S. Pat. No. 5,300,031, the entirety of which is hereby incorporatedby reference.

In the illustrated application, in which the injector receives multiplesyringes, a user-filled syringe having a volume of about 200 ml ismountable in a pressure jacket 250 of faceplate 88 a. Further, apre-filled syringe having a volume in excess of about 90 ml or more mayalso be mountable in faceplate 88 b. The injector powerhead 90 includeshand-operated knobs 92 a and 92 b that are operative via an injectorcontrol circuit to control motors within respective plunger drives 95 a,95 b. The plunger drives 95 a, 95 b are operable to move plungers withinthe respective syringes 20 a, 20 b in a known manner. Exemplaryoperations of a powerhead 90 and injector control 93 are shown anddescribed in U.S. patent application Ser. No. 10/964,002, the entiretyof which is hereby incorporated herein by reference. Additionalexemplary operations are described in U.S. Pat. Nos. 5,662,612,5,681,286 and 6,780,170, the entirety of which are hereby incorporatedby reference. As seen in FIG. 3A, the injector control 93 iselectrically connected to the hospital information system 78 via thecommunications link 80, and/or may be otherwise electrically connectedto the imaging information system 87 by a communications link that usesa technology such as those noted above with reference to thecommunications link 80.

The injector powerhead 90 has a user interface 94, for example, a touchscreen, for displaying current status and operating parameters of theinjector 50. Powerhead 90 is often mounted to a wheeled stand 100, whichpermits easy positioning of the powerhead 90 in the vicinity of theexamination subject 52. The injector 50 also has a remotely locatedconsole 96 with remote user interface 97, for example, a touch screen, apower supply 98 and other switches and components (not shown). Theconsole 96 may be used by an operator to enter programs and control theoperation of the injector 50 from a remote location in a known manner.It will be appreciated that elements of the injector control 93 may beincorporated into the powerhead 90 or may be incorporated in otherelements of the injector such as the power supply 98 or console 96, ormay be distributed among these elements.

Referring to FIGS. 5C and 5D, the powerhead user interface 94 andconsole 96 provide a display screen 91 (FIG. 5D) displaying graphicrepresentations 20 cc, 20 dd of the respective syringes 20 c, 20 dmounted in the powerhead 90. In addition to the powerhead and console96, the display screen 91 in FIG. 5D may also be displayed on thescanner. Syringe 20 c has an RF-ID tag 60 c that is displayed as graphicicon 60 cc. Syringe 20 d does not have an RF-ID tag, and hence, there isno RF-ID tag display. When the RFID graphic 60 cc is selected by anoperator, the data contained on the RFID tag 60 c is displayed on thetouch screen 91. Displaying the tag information allows the operator toview and check the data at any time before as well as allowing access ina history file after, an injection has been performed. The RFID tag 60 cis capable of storing the various data values described herein; andthus, the information displayed on the touch screen 91 may include, butis not limited to, the amount of contrast media in the syringe, theidentity or type of the contrast media in the syringe, manufacturinginformation for the contrast media in the syringe, a radioactivity levelof a radiopharmaceutical contrast media in the syringe, a use code forthe contrast media in the syringe, configuration information forpowerhead 90 used with the syringe, a lot number, and/or an expirationdate and other information.

The faceplate 88 b has an outward extending cradle 99 that supports aheater 106 mounted on a printed circuit (“PC”) board 102. The heater 106is electrically connected to the injector control via a cable orconnector and is operable by the injector control 93 to heat the syringe20 b in a known manner. The PC board 102 further supports a R/W device104 b and an associated antenna system 229 b. The R/W device 104 b isalso electrically connected to the injector control 93 and console 96.Further, the R/W device 104 b may be activated by the injector control93 to read data from an RFID tag 60 b on a respective syringe 20 b. Datamay be written to, and/or read from, the RFID tag 60 b at any specifiedtime when a syringe 20 b is in proximity of a respective faceplate 88.Thus, the system has the ability to determine when syringes 20 a, 20 bare mounted in the respective faceplates 88 a, 88 b. The data may beencrypted, and the data and data transfer may comply with 21 CFR 11,JCAHO, and HIPAA requirements.

One example of a process for utilizing the syringe 20 b within theimaging suite 26 a is shown in FIG. 8. This example is describedprincipally with respect to the syringe 20 b loaded in faceplate 88 b;however the description is equally applicable to the syringe 20 a loadedin faceplate 88 a. The description is further applicable to an injectionprocess in which media is dispensed from both syringes 20 a, 20 b,either sequentially or simultaneously. Simultaneous dispensing from bothsyringes may be done at controlled and selected flow rates to achieveany desired concentration of the resulting mixture of media and/or mediaand saline in the two syringes.

Referring to the process of FIG. 8, first, at 702, the R/W device 104 bis activated to read data stored in the RFID tag 60 b relating tocontrast media or other pharmaceutical and its associated prefilledsyringe or other container 20 b. As shown at 704, that informationincludes, but is not limited to:

-   -   A container identification and/or serial number that is checked        against a database of previously used containers to block, if        appropriate, a potential reuse of the container.    -   A container security code, which may be matched with the        security code of the injector being used.    -   Information relating to container volume and volume delivery to        assist the technologist in setting up the injector.    -   Container volume and/or dimension information in order to        provide a more precise real time dispensing control of volume.    -   Pharmaceutical type and concentration data to confirm it is        correct for a selected protocol.    -   ID, batch and lot numbers that can be used to test the container        and/or pharmaceutical against recall data.    -   Shelf life data and fill date, which is compared to a current        date to determine whether a recommended shelf life has been        exceeded.

The R/W device 104 b also writes the current time and date to the RFIDdevice 60 b to permit tracking of open-to-atmosphere time for thesyringe 20 b, which is also limited. During the contrast media injectionprocess, the displacement of the syringe plunger is precisely controlledin accordance with data read from the RFID tag 60 b relating toavailable syringe volume and/or dimensions thereof. Further, plungerfeed is tracked, so that the contrast media remaining in the syringe canbe continuously determined.

The faceplates 88 a, 88 b have a bidirectional communications link withthe injector control 93, which may be used to transfer any of the aboveinformation between the syringes 20 a, 20 b and the injector control 93.Thus, the injector control 93 may have syringe and drug information thatmay facilitate a procedure setup and result in reduced time and error.In addition, the injector control 93 may read or write other informationto and from the faceplates 88 a, 88 b, which is not directly pertinentto syringe information. Examples of this may include, but are notlimited to:

-   -   Enabling or disabling of the faceplate electronics.    -   Heating of the faceplate for contrast media warming.

In step 706 of FIG. 8, the media is used in connection with a procedure.As seen in FIG. 4, before, during and after injection of the contrastmedia, a technologist operates a CT scanner control 101 that iseffective to cause a CT scanner 103 to scan a patient 105 shown inphantom. The injector control 93 may have one or more interfaces to aCAN communications bus 111, which is a known interface for the CTscanner control 101. The protocol is defined by the scannermanufacturers. Data and data transfer between the injector and scannercomply with 21 CFR 11, JCAHO, and HIPAA requirements.

Returning to FIG. 8, as shown at 706, data transfer between the injectorcontrol 93 and CT scanner control 101 may be bidirectional and mayrelate to the contrast media or other pharmaceutical and its associatedprefilled syringe or other container 20 b. Such data includes, but isnot limited to, the following:

-   -   Pharmaceutical brand name, concentration, lot number.    -   Pharmaceutical expiration date, volume.    -   Injected volume, flow rate (achieved, target).    -   Injection time.    -   Patient name, weight, age, ID number, for example, SS no.,        hospital ID, etc.    -   Injector serial number, firmware version.    -   Procedure number and/or name.    -   Technologist name and/or identification number.    -   Hospital name and/or identification number.    -   Used or unused status of container.    -   CT scanner setup and procedure information.    -   CT scanner ID and/or serial no.    -   CT images.    -   Hospital information system data.    -   Injector functional control.    -   CT scanner functional control.

Upon the injector control 93 determining that the desired volume ofcontrast media has been delivered, the injection process is stopped. Atthe end of the injection process, as shown in FIG. 8 at 708, theinjector control 93 is operative to determine an exact volume ofcontrast media injected; and the injector control writes to the RFID tag60 b and/or updates the imaging information system 87 with data andinformation that includes, but is not limited to the following:

-   -   Time and date that the injection process was finished.    -   Injected volume, flow rate (achieved, target).    -   Volume of pharmaceutical remaining in the container.    -   Injection time.    -   Patient name, weight, age, ID number, for example, SS no.,        hospital ID, etc.    -   Injector serial number, firmware version.    -   Procedure number and/or name.    -   Technologist name and/or identification number.    -   Hospital name and/or identification number.    -   Used or unused status of syringe.    -   CT Scanner Information.

As illustrated in FIG. 4, the injector control 93 has an interfaceproviding a communications link 107 to a hard-copy printer 109. Theprinter 109 may be, but is not limited to, a thermal, ink-jet, or laserbased printer. The printer 109 may be used to print pages and/or labelsof various sizes and colors at specified times upon requests of a user,the CT scanner control 101, the hospital information system 78, or theinjector control 93. The labels may be made part of patient records,requisition sheets, or other forms. Data output and data transfer maycomply with 21 CFR 11, JCAHO, and HIPAA requirements.

Returning to FIG. 8, as shown at 710, a label or page may be printed toprovide information relating to the contrast media or otherpharmaceutical, its associated prefilled syringe or other container 20b, and the use thereof. Such information includes, but is not limitedto, the following:

-   -   Pharmaceutical brand name, concentration, lot number.    -   Pharmaceutical expiration date, volume.    -   Injected volume, pressure, flow rate (achieved, target).    -   Injection time.    -   Patient name, weight, age, ID number, for example, SS no.,        hospital ID, etc.    -   Injector serial number, firmware version.    -   Procedure number and/or name.    -   Technologist name and/or identification number.    -   Hospital name and/or identification number.    -   Used or unused status of syringe.    -   Graphs or charts, for example, pressure, flow rate, etc.    -   CT scanner information.    -   CT scan information.    -   Open (white) space or blanks for tech initials, drawings, etc.

Thus, any of the above information can be exchanged between the injectorcontrol 93 and hospital information system 78. Potential uses for thiscapability include but are not limited to:

-   -   Electronic inclusion of volume of contrast media injected and        other procedure information in patient record.    -   Electronic re-ordering of supplies.    -   Automated billing.    -   Automated scheduling.

After the injection process, the injector control 93 can write to theRFID tag 60 b to set a syringe-used flag that will help to prevent areuse of the syringe 20 b. The syringe 20 b is then removed from thefaceplate 88 b; and if the procedure was aborted and the syringe was notused, it can be placed back into the warmer 36. In that process,information is read from, and written to, the RFID tag 60 b aspreviously described. Further, the image information system 87 is alsoable to track the open-to-atmosphere time of the syringe and warn thetechnologists when an open-to-atmosphere time is exceeded.

If the syringe 20 b removed from the faceplate 88 b is empty, thesyringe is typically transported to a disposal area 112 (FIGS. 1A, 3Aand 4); and prior to disposal, another R/W device 114 connected to oneof the other computers 75 reads the RFID tag 60 b. The inventorydatabase 76 can thus track the identity of the syringe 20 beingdestroyed. Further, the syringe disposal information can be communicatedto a supplier computer 116 via a communications link 118 as seen in FIG.3A, for example, via the Internet 83, a telephonic connection, or othercomparable wired or wireless connection.

In an alternative embodiment, empty syringes, instead of beingdestroyed, are returned to the supplier 24 for further processing, forexample, disposal or refilling. In the latter example, the syringes 20pass through the hospital shipping/receiving area 44 and the RFID tagsare again read to identify the syringes leaving the hospital; and theinventory database 76 is updated accordingly. Upon entering the suppliershipping/receiving area 38, the RFID tags 60 b are again read to updatea supplier inventory database 120 tracking syringes within thesupplier's facilities. The RFID tags 60 b on the syringes 20 are updatedor replaced depending on whether the syringe is destroyed orreconditioned and refilled by the supplier.

In the system shown and described herein, the injector control 93facilitates information collection and transfer throughout a CTprocedure. The RFID-enabled syringes provide quicker and more accuratedata recording, as well as an automated transfer of drug information.The printer allows for a hard copy of selected information to beincorporated into the patient or hospital record. The CT interface viaCAN, facilitates information flow and collection at a single point,either the CT scanner system or the injector. The hospital informationsystem interface improves this information flow a step further,potentially creating an all-electronic system with minimal userintervention; this provides the opportunity for reduced error andefficiency in the CT scanning suite.

With respect to another exemplary embodiment, on occasion, fieldengineers make service calls to a power injector, e.g. for routinemaintenance or to diagnose failed operation. During such service calls,the field engineer is able to operate the injector in a “service” modewithout having to install electrical jumpers in the injector control.Instead, referring to FIG. 5B, the service mode function is initiated bya field engineer using an intelligent identification (“ID”) card 122.Such an ID card 122 has an RFID tag 124 that incorporates an RFID chipand associated antenna in a known manner.

An exemplary process for using the ID card 122 for injector maintenanceis shown in FIG. 9. As indicated at 802, the RFID tag 124 is loaded atthe supplier facility 24 with data including, but not limited to, thefollowing:

-   -   An identification of the field engineer.    -   Latest updates and software information.    -   Specific software revisions.

To initiate service of a power injector, the field engineer places theID card 122 on an empty faceplate 88 b, thereby allowing the R/W device104 b to read and write to the RFID tag 124. As indicated at 804 of FIG.9, upon reading an appropriate identification and security code from theRFID tag 124, a field engineer identification and service time and dateare stored in the injector control 93. Thereafter, the injector userinterfaces 94, 97 (see FIG. 5A) are effective to switch the injector 50into a service mode, thereby disabling several operational checks andfeatures that are used in a normal injection cycle but which inhibitoperating the injector 50 for service purposes. The R/W device 104continues to periodically read the identification and security codesfrom the RFID tag 124. Upon failure to successfully read the RFID tag124, for example, because the ID card 122 has been removed from thefaceplate 88 b, the injector control 93 automatically switches theinjector 50 out of the service mode. Thus, the previously disabledoperational checks and features are re-enabled, and the injector isready to operate in a normal injection cycle. Further, at 804, theinjector control 93 is operative to read from the RFID tag 124information and data relating to factory updates to the injectorcomponents and software.

In the process of servicing the injector 50, as indicated at 806, thefield engineer initiates uploads of software upgrades from the RFID tag124 to the injector control 93. In addition, mechanical components areserviced, mechanical upgrades are installed and their operation isverified. As a final step of the service operation as indicated at 808,the injector control 93 writes to the RFID tag 124 on the ID card 122data including, but not limited to, the following:

-   -   The latest software revision installed.    -   A confirmation that mechanical and software upgrades have been        installed.    -   The date of service and serial number of the injector.    -   Protocol, statistics or details relating to the injector        operation since the last service.

Upon the field engineer returning to the supplier facility 24, the RFIDtag 124 is read; and the service information is stored in a history fileassociated with the particular injector that was serviced.

The use of an RF communications system between an RFID tag 60 on acontainer 20 and a power injector control 93 provides for furtherexemplary embodiments of the RF communications system. Known RFIDsystems use electromagnetic (EM) fields to communicate between an R/Wdevice that includes a tuned antenna and one or more RFID tags ortransponders. In one exemplary embodiment, the R/W device sends out datausing EM fields at a specific frequency; and with passive RFID tags,this EM energy powers the tag, which in turn enables processing of thisreceived data. Following receipt of the data, the RFID tag may transmitdata that is received and processed by the R/W device.

An RFID is difficult to implement around metallic or diamagneticmaterials, for example, water, saline or a medical fluid in a containersuch as a contrast media in a syringe. These materials absorb and/orreflect RF energy, making successful read-write RFID operationsdifficult, especially with the low power regulations for RF frequencies.In addition, the angle between a plane of the RFID tag antenna and aplane of the R/W device antenna is critical. For optimum performance,the plane of the RFID tag antenna should be substantially parallel tothe plane of the R/W device antenna. As shown in FIG. 10, for singleplane antennas, as an acute angle 200 between an RFID tag antenna plane202 and an R/W device antenna plane 204 increases, a signal strengthcoupling the antennas in the two planes 200, 204 decreases. In otherwords, as the angle 200 increases, the RF signal strength transferablefrom the R/W device antenna to the RFID tag antenna decreases.Similarly, the signal strength transferable from the RFID tag antennaback to the R/W device antenna also diminishes. Further, that signalstrength is substantially equal to the output signal strength of the R/Wdevice antenna minus any attenuation from metallic and diamagneticmaterials divided by the cosine of the angle 200.

Referring back to FIG. 5A, orientation of the syringe 20 b places theRFID tag antenna 210 relatively close to the R/W device 104 b; andtherefore, coupling RF signals therebetween to facilitate reading datafrom, and/or writing data to, the RFID tag 60 b. However, with thesyringe 20 b oriented as shown in FIG. 11, contrast media in the syringe20 b is between the RFID tag antenna 210 and the R/W device 104 b. Thecontrast media attenuates the RF field strength from the antenna of theR/W device 104 b and interferes with its RF coupling with the RFID tagantenna 210.

In one exemplary embodiment of the invention, referring to FIG. 12, asyringe 20 b having a label 30 b with an antenna 210 and RF driver 212is positioned above faceplate 88 b, ready to be loaded therein. A firstPC board 102 and a second PC board 103 are mounted in faceplate 88 b, soas to be nonparallel. The PC boards 102, 103 form sides of a V-shape andthus, form an angle of less than 180 degrees therebetween. PC board 102supports a first antenna loop 220 and its associated tuning circuit 226,and PC board 103 supports a second antenna loop 222 and its associatedtuning circuit 228. The first and second antenna loops 220, 222 andrespective tuning circuits 226, 228 are connected to an R/W RF drivercircuit 224 b through a switching circuit 241 b to collectively form theelectromagnetic R/W device 104 b. In an alternative embodiment, the R/WRF driver circuit 224 b and switching circuit 241 b may be mounted on aseparate PC board 102 b (shown in phantom), which is located beneath,and electrically connected to, the PC board 102. In other embodiments,the R/W RF driver circuit 224 b and/or the switching circuit 241 b maybe mounted in the power head 90 in association with the injector control93.

Further, as shown in FIGS. 13A-13D, an antenna system 229 b comprisingthe antenna loops 220, 222, respective tuning circuits 226, 228 andswitching circuit 241 b is connectable in different electricalconfigurations to achieve an optimum RF coupling between the R/W device104 b and the RFID tag 60 b.

Referring to FIG. 13A, power from the R/W RF driver circuit 224 b isapplied to the input 230 of a tuning circuit 226 that is connected to asignal lead 231 of the primary antenna loop 220 on PC board 102.Further, input 234 of the tuning circuit 228, which is connected to asignal lead 235 of the secondary antenna loop 222 on PC board 103, isleft open or floating. A primary antenna loop ground lead 232 isconnected to ground with the secondary antenna loop ground lead 236. Inthis configuration, the powered primary antenna loop 220 on PC board 102is tuned to a frequency indicated by a protocol of the RFID tag 60 b,for example, about 13.56 Megahertz, which permits propagation of the RFsignal into the surrounding area. An RF signal from the primary antennaloop 220 is coupled with the secondary antenna loop 222 on PC board 103,because the secondary antenna loop 222 is also tuned to resonate atabout 13.56 Megahertz.

The angled, V-shape orientation of the PC boards 102, 103 and respectiveareas of antenna loops 220, 222 provide an expanded or increased totalantenna area for the R/W device 104 b. Thus, with the antennaconfiguration of FIG. 13A, as shown in FIG. 12, an effective antennaarea extends circumferentially around a substantially greater area of asyringe 20 b than is possible with the single PC board 102 shown in FIG.5A. Further, the antenna power provided by the RF driver circuit 224 bis also spread over a larger area represented by the combined areas ofantenna loops 220, 222. Upon the syringe 20 b being loaded onto thefaceplate 88 b, with some orientations of the syringe 20 b, the largerantenna area shown in FIG. 13A improves the RF coupling with the antenna210 of the RFID tag 60 b.

As shown in FIG. 13B, antenna loop 222 on PC board 103 can be made theprimary loop by disconnecting or opening an input 230 of the tuningcircuit 226 and connecting the tuning circuit input 234 of the antennaloop 222 to the power output of the R/W RF driver circuit 224 b. Firstantenna loop ground lead 232 and second antenna loop ground lead 236continue to be connected to ground. Again, both antenna loops 220, 222are tuned to resonate at the RFID tag frequency, that is, about 13.56Megahertz. The antenna configuration of FIG. 13B may provide better RFcoupling with the antenna 210 of the RFID tag 60 b depending on theorientation of the syringe 20 b and thus, the circumferential locationof the RFID tag 60 b.

Another configuration of the antenna loops 220, 222 is shown in FIG. 13Cwherein the tuning circuit input 230 of the first antenna loop 220 isconnected to the power output of the R/W RF driver circuit 224 b; andfirst antenna loop ground lead 232 is connected to ground. The tuningcircuit input 234 and ground lead 236 of antenna loop 222 are connectedto ground, which prevents the second antenna loop 222 from resonating atthe RFID tag frequency, which, in this application, is 13.56 MHz. Thiseffectively reduces the area of the antenna system 229 b to the area ofthe primary antenna loop 220, and all of the power from the R/W RFdriver circuit 224 b is applied across the area of the primary antennaloop 220, which is tuned to resonate at the RFID tag frequency, that is,about 13.56 Megahertz. Upon the syringe 20 b being loaded onto thefaceplate 88 b, depending on the orientation of the syringe 20 b and theRFID tag antenna 210, the smaller antenna area of the circuit in FIG.13C may improve the RF coupling with the antenna 210 of the RFID tag 60b.

Referring to FIG. 13D, alternatively to FIG. 13C, the tuning circuitinput 234 of the second antenna loop 222 on PC board 103 is connected tothe power output of the R/W RF driver circuit 224 b; and tuning circuitinput 230 of the first antenna loop 220 is connected to ground alongwith antenna loop ground leads 232 and 236. Thus, the first antenna loop220 does not resonate at the RFID tag frequency of 13.56 MHz; and onlythe second antenna loop 222 is tuned to resonate at that frequency. Withsome orientations of the syringe 20 b, this antenna configurationprovides the best RF coupling with the antenna 210 of the RFID tag 60 b.

In some applications, a user may be instructed to load the syringe 20 bin the faceplate 88 b so that the label 30 b is always in the sameorientation. Or, in other applications, the RFID tag 60 b may beremovable from the syringe and mountable at a fixed location on theinjector 50. In those applications, an R/W antenna can be designed andplaced in a fixed location to have optimum RF coupling with an RFID tag.However, in still further applications, a user may have no limitationson where the RFID tag 60 b is located on the syringe 20 b or how theRFID tag 60 b is oriented when the syringe 20 b is mounted on afaceplate 88 b. In those applications, the RFID tag 60 b may have anycircumferential location around a barrel of the syringe 20 b or withinthe faceplate 88 b. Further, in such applications, it is difficult toprecisely predict which of the antenna configurations in FIGS. 13A-13Dwill provide the best RF coupling with an RFID tag having an unknownorientation with respect to R/W device 104 b. This is due, in part, tothe complex and somewhat unpredictable EM fields formed around materialsthat reflect and/or absorb such fields. Therefore, in another exemplaryembodiment of the invention, all of the antenna configurations of FIGS.13A-13B may be utilized.

Referring to FIG. 14, switches 238, 240 on PC board 102 comprise theswitching circuit 241 b, which is used to selectively connect respectivetuning circuit inputs 230, 234 to either a power output or terminal 242from R/W RF driver circuit 224 b, a ground terminal 244 or an open staterepresented by contacts 246. The ground leads 232, 236 of respectiveantenna loops 220, 222 are always connected to the ground 244. Thecontacts of switches 238, 240 have notations to FIGS. 13A-13D indicatingthe switch states corresponding to the antenna configurations of FIGS.13A-13D.

In use, referring to FIGS. 12 and 15, a communications cycle isinitiated either automatically by the injector control 93 detecting asyringe 20 b being loaded into the faceplate 88 b (such as by themovement of a mounting arm of the faceplate 88 b, causing a magnet inthe mounting arm to move into confronting relationship with a magneticsensor in the injector), or manually by an operator providing an inputto the injector control 93. In either event, the injector control, at900, operates the switches 238, 240 to connect the antenna loops 220,222 in a first of the four circuit configurations, for example, thecircuit configuration shown in FIG. 13A. Thereafter, the injectorcontrol 93 initiates, at 902, a communications protocol between the R/WRF driver circuit 224 b and the RF driver circuit 212 of the RFID tag 60b. Initiating a communications protocol is a known process by which theR/W RF driver circuit 224 b causes the R/W antenna system 229 b to emitan electromagnetic signal in order to establish a reliable RF couplingwith the tag antenna 210 and thus, establish an RF communications withthe RFID tag 60 b. Upon establishing an RF communications, the R/Wdevice 104 b can read data from and/or write data to the RFID tag 60 b.

If, at 904, the injector control 93 determines that the communicationsprotocol and hence, the RF communications link, has been established,the injector control 93 commands, at 906, the R/W drive 104 b to proceedwith the reading of data from, and/or the writing of data to, the RFIDtag 60 b. However, if, at 904, the injector control 93 determines thatthe communications protocol failed, and a successful RF communicationsbetween the R/W device 104 b and the RFID tag 60 b is not made, theinjector control 93 determines, at 908, whether all antenna loopconfigurations have been tried. If not, the injector control 93operates, at 910, the switches 238, 240 to connect the antenna loops220, 222 into another one of the four circuit configurations shown inFIGS. 13A-13B. Thereafter, the injector control 93 automaticallyiterates through the process steps 902-908 to reconnect the antennaloops 220-222 in different circuit configurations in an attempt toestablish a successful RF communications protocol or link. If, at 908,the injector control 93 has tried all of the antenna loop configurationswithout success, it sets, at 912, a protocol failure flag or errormessage.

FIGS. 11-14 illustrate different embodiments of an antenna system 229 bthat may be employed with an electromagnetic R/W device 104 b to read adata tag 60 b applied to a syringe 20 b mounted in an open faceplate 88b. In a further embodiment, referring to FIG. 5A, a syringe 20 a, thatoften is a user-filled disposable syringe, is mounted within atranslucent or transparent pressure jacket 250 of faceplate 88 a. Thesyringe 20 a is secured in the pressure jacket 250 by a cap 252 in aknown manner. A data tag 60 a is integrated into a label 30 a applied tothe syringe 20 a, and the structure and operation of data tag 60 a issubstantially identical to the data tag 60 b previously described. Whenutilizing the pressure jacket 250 of faceplate 88 a, it is desirablethat the data tag 60 a be readable regardless of its orientation insidethe pressure jacket 250.

Referring to FIGS. 5A and 16, in a further exemplary embodiment of anRFID communications system, to enhance readability of a data tag 60 a,the pressure jacket 250 may be equipped with an antenna system 229 a,which includes of an array of antenna loops 254, 256, 258 spaced about acircumference of the syringe 20 a. While equal spacing of the antennaloops is shown, other spacing may be used. The pressure jacket 250 hasinner and outer cylindrical sleeves 260, 262, respectively. Asillustrated, the antenna loops 254, 256, 258 may be molded between theinner and outer sleeves 260, 262. Referring to FIG. 17, the antennaloops 254, 256, 258 have respective tuning circuits 264, 266, 268, whichmay be molded between the inner and outer cylindrical sleeves 260, 262.Tuning circuit input leads 270, 272, 274 and a ground lead 276 may bebundled into a cable 278 that extends from the face plate 88 a to aswitching circuit 241 a located in the power head 90. The switchingcircuit 241 a may operate in any appropriate manner, such as in a mannerlike that previously described with respect to the switching circuit 241b of FIG. 14. The switching circuit 241 a may be controlled by an R/Wdriver circuit 224 a that may be located in the power head 90. Toexchange data with the data tag 60 a, the R/W driver circuit 224 a mayexecute a communications cycle utilizing the antenna loops 254, 256, 258in a manner similar to that described with respect to FIG. 15. Thus, ininitiating communications with the data tag 60 a, the R/W RF drivercircuit 224 a may connect the antenna loops 254, 256, 258 in differentcircuit configurations in order to find a circuit configurationproviding the most reliable communications with the data tag 60 a. Byusing more than two antenna loops, less power may be required toinitiate a communications cycle with the data tag 60 a. In additionalexemplary embodiments, while the antenna system 229 a is shown asincluding three antenna loops, other embodiments may include otherappropriate quantities and/or arrangements of antenna loops. Further,while the antenna system 229 a is shown as a component of the pressurejacket 250, other embodiments may include an antenna system having aplurality of antenna loops that is not associated with a pressurejacket.

In its various embodiments, the antenna systems 229 a, 229 b mayadvantageously incorporate one or more antenna loops that can be poweredindividually, or mutually coupled together, to produce several tunedantenna and EM field configurations. In some environments, the antennasystems 229 a, 229 b may be characterized as providing an effective lowpower system for reading data from and/or writing data to a data tagthat may be disposed at any location on a contrast media syringe.Moreover, that contrast media syringe may exhibit virtually anyorientation relative to a faceplate of a power injector 50 with which itmay be associated. Thus, the antenna systems 229 a, 229 b may positivelyaddress various challenges relating to use of an RF communicationssystem around metallic or diamagnetic materials, e.g., water, saline,contrast media, or other fluids, and/or in a regulated environment thatmay mandate use of a relatively low power RF signal.

The exemplary embodiments described with respect to FIG. 1A relategenerally to a life cycle of a container 20 such as a syringe filledwith a pharmaceutical such as a contrast media. However, referring toFIG. 1B, a container life cycle 18 b may relate to other types ofcontainers 20 c that are used to store radiopharmaceuticals. While muchof the container life cycle 18 b of FIG. 1B is generally similar tocontainer life cycle 18 a of FIG. 1A, radiopharmaceuticals requiredifferent handling and storage. The container 20 c is schematicallyshown as a syringe, but the container 20 c may be a vial or othercontainer suitable for use with a radiopharmaceutical. Within thesupplier facility 24, after the container 20 c is filled with aradiopharmaceutical at a drawing-up or filling station 28, a qualitycontrol check of the radiopharmaceutical may be performed at qualitycontrol station 31. Thereafter, the container 20 c is placed or loadedinto a pig 33, which generally includes lead and/or other radiationshielding material to protect handlers from exposure to radiation fromthe radiopharmaceutical.

In a manner similar to that described with respect to container 20 ofFIG. 1A, as shown in FIG. 1B, the loaded pig 33 may then be packagedeither singularly or as a batch in an appropriate shipping carton 34 andshipped to a customer or user. Often, the cartons 34 are stored in anuclear medicine department 29 within the hospital 42, which generallyincludes a radiopharmacy 48 and treatment room 26 b. As required, aradiopharmaceutical container may be removed from a pig and placed in acalibration tool 49 to calibrate an activity level of theradiopharmaceutical to a desired level prior to its use. Theradiopharmaceutical container may then be placed back into the pig; andat an appropriate time, the pig may be carried to a treatment room 26 b.The radiopharmaceutical container may again be removed from the pig, andthe radiopharmaceutical may be injected into a patient 52 eithermanually or using a powered injector such as that shown and describedherein. In various embodiments, different manual or powered injectorsmay utilize various principles of the invention, and are thus, includedwithin the scope of this disclosure.

After use, the radiopharmaceutical container may be placed in the pigand returned to the supplier facility 24; and at a post processingstation 51, the radiopharmaceutical container may be disposed of and thepig may be cleaned for reuse.

An exemplary embodiment of a radiopharmaceutical container draw-up andpackaging process implemented at a supplier facility 24 is illustratedin FIG. 6. A radiopharmaceutical container 20 c is filled, at 502, witha radiopharmaceutical at a draw-up station 28. Thereafter, at 504, alabel 30 and/or RFID tag 60 are applied to the radiopharmaceuticalcontainer 20 c at the labeling station 32. The RFID tag 60 can beintegrated with, or separate from, the label, and the RFID tag 60incorporates an RFID chip and associated antenna in a known manner.

As shown in FIG. 18, the RFID tag 60 can be applied at any suitablelocation on a radiopharmaceutical container. For example, the RFID tag60 can be part of a label 30 that is applied to a radiopharmaceuticalsyringe 20 d or a radiopharmaceutical vial 20 e. In the example of theradiopharmaceutical syringe 20 d, an RFID tag can be applied to, orintegrated into, the syringe structure at different locations aspreviously described with respect to FIGS. 2A-2D. In a furtherembodiment, the syringe label 30 may be removable; and immediately priorto the syringe 20 d being loaded into a power injector, a portion of thelabel 30 including the RFID tag can be peeled off and applied to theinjector or an associated reader. Upon removing the radiopharmaceuticalsyringe 20 d from the injector, the RFID tag 30 is reapplied to theradiopharmaceutical container 20 d. An identical or different label 30can also or alternatively be applied to a radiopharmaceutical syringepig 33 a or a radiopharmaceutical vial pig 33 b. Further, a label 30with an RFID tag 60 can be applied to a carton 34, for example, asatchel, designed to transport a plurality of pigs.

Within the supplier facility 24 of FIG. 1B, a read/write (“R/W”) device62 is connected to a label computer 64 and, at 506 (FIG. 6), isoperative to read data from and/or write data to the RFID tag 60 for aparticular radiopharmaceutical container 20 c. As shown in FIG. 3B, thedraw-up station 28 may include a draw-up station computer 41 inelectrical communications with an R/W device 43; and depending on theapplication, either or both of the R/W devices 43, 62 can be used towrite data to the RFID tag 60, which data includes but is not limited tothe data previously described with respect to step 506. With aradiopharmaceutical, the data may also include all of the dose andprescription information that is currently being printed on aprescription label and/or encoded into a bar code, measuredradioactivity levels, for example, Tc-99 and Mo-99, and time whenmeasured, an identity of radioactive elements used, for example, Tc-99and Mo-99, their respective sources, and other suitable data.

Returning to FIG. 6, processes shown in phantom at 507 and 509 areperformed that are unique to the radiopharmaceutical containers 20 c.First, at 507, quality control checks may be performed (e.g., at aquality control station 31) to determine, for example, a purity of theradiopharmaceutical, the correctness of information on the label, dosageinformation, etc. As shown in FIG. 3B, the quality control station 31may include a quality control computer 45 and an associated R/W device47 that may be used to read data from and/or write data to the RFID tag60 depending on the quality control checks performed and/or other systemspecifications.

The container 20 c may then, at 509, be inserted into a pig 33 forhandling, storage and transportation. A label 65 can optionally beapplied to the pig 33. The label 65 can include human readable indicia,machine readable indicia and/or an RFID tag as described with respect tothe label 30. As part of the process of inserting the container 20 cinto the pig, either the R/W device 62 or another R/W device can be usedto read data from and/or write data to the RFID tag 65. Data that can bewritten to the RFID tag 65 may include data written to the RFID tag 60on the container 20 c as well as data that includes, but is not limitedto, the following:

-   -   A unique identification number for the pig.    -   An identity of a factory, production line, and/or batch number        associated with the pig.    -   A date and time at which the container was inserted into the        pig.    -   Any other data associated with the order, the        radiopharmaceutical, its container 20 c and associated pig 33.

At 508 in FIG. 6 (in a manner similar to that previously described withrespect to FIG. 1A), one or more pigs 33 may be loaded into a shippingcarton 34 (see FIG. 1B). At 510, the cartons 34 may be stocked asinventory in a shipping/receiving department 38. Based on ordersreceived, as indicated at 512, the cartons 24 may be further combined orpalletized into a case or batch 67 for shipment to a customer; and alabel 66 can be optionally applied to an individual shipping carton 34or a unified case or batch 67 of cartons.

Referring to FIGS. 1B and 7, the cartons 34 may then enter thedistribution channel 40 and may be received by a receiving department 44of a treatment facility such as the hospital 42. A stocking andpreparation process may be executed in process steps 602 and 604, whichare similar to those previous described. Also in step 606, cartons maybe delivered to a hospital radiopharmacy 48 (or nuclear medicinedepartment of a healthcare facility or other appropriate location), andwithin the radiopharmacy 48, an R/W device 77 connected to a computer 79can be used to read data from and/or write data to the pig RFID tags 65.As shown in FIG. 3B, the computer 79, via the communications link 80,can also be used to update the medicine tracking database 76 within thehospital administration computer 78.

Processes unique to radiopharmaceutical containers are shown in phantomat 607 and 609 in FIG. 7. Specifically, within the radiopharmacy 48, acalibration tool 49 is often used, at 607, to check or validate aradioactivity level of the dosage of the radiopharmaceutical within acontainer. This check/validation can be performed using any appropriateprocess and/or calibration tool. As shown in FIG. 3B, the calibrationtool 49 may have a calibration computer 85 connected to an R/W device 89that, during the check/validation process, can be used to read data fromand/or write check/validation data to the container RFID tags 30 and/orthe pig RFID tags 65. This check/validation data may include but is notlimited to

-   -   A check/validation time and date.    -   The decay factor or half life of the radiopharmaceutical.    -   The prescribed activity level (curie level of radiation) at        injection time.    -   The activity level at another time, for example, the draw-up        time.    -   A measured radioactivity level.    -   A desired radioactivity level at time of treatment.    -   An identity of the radioactive element injected.    -   An identity of the calibration tool and operator, etc.

Continuing in FIG. 7, at the appropriate time, at 609, a pig 33 may bedelivered to a treatment room for use. The radiopharmaceutical can beadministered manually or using a power injector. In most, but not allcases, a syringe 20 d or vial 20 e containing the radiopharmaceutical isremoved from a respective pig 33 for manual administration; but in otherapplications, a power injector and process as previously shown anddescribed with respect to FIG. 8 may be used. With aradiopharmaceutical, the R/W device 104 associated with the injectorcontrol 93 (see FIG. 3B) may write the current time and date to the RFIDtag 60 to permit tracking of out-of-pig time (e.g., the duration of timethat a syringe or vial is not housed within the pig), if desired. Duringthe radiopharmaceutical injection process, the displacement of theradiopharmaceutical container plunger may be precisely controlled, andplunger feed may be tracked (e.g., recorded and written to a tagassociated with syringe and/or pig).

It should be noted that labeling systems described herein have potentialfor eliminating a need for the calibration tool 49. For example, the R/Wdevice 104 of FIG. 3B can read a radioactivity level and time and dateof measurement written into the RFID tag by the quality control station31 (FIG. 1B). Injector control 93 can then calculate the time elapsedbetween the measured radioactivity level and the scheduled treatmenttime and date. The injector control 93 can further calculate the decayin radioactivity level over the elapsed time; and then, being programmedwith the prescribed radiopharmaceutical dose, the injector control cancalculate the correct unit dose volume to be injected. Thus, acalibration tool 49 may not be required. If the radiopharmaceutical isto be injected manually, the computer 79 and associated R/W device 77can be used by a clinician or other appropriate personnel in a similarfashion to provide a display of the computed current unit dosage withoutusing a calibration tool.

After the injection process, referring to FIGS. 1B, 5A and 19, theradiopharmaceutical container 20 c may be removed from the faceplate 88b and placed back into a respective pig 33 as indicated at 802 in FIG.19. The pig 33 may then be placed in the same or a different carton and,at 804, returned to the shipping department 44 and, at 806, returned tothe supplier facility 24. As shown in 807, the label associated with theradiopharmaceutical container may be read just prior to disposal toassist in determining how long the container will have to be stored in aradiation-shielding disposal and/or storage container beforesubstantially all of its radioactivity has decayed. For instance, theinitial radioactivity of the radiopharmaceutical may be written to thetag at the time of filling the container. Subsequent to that initialfill time, the radioactivity of that radiopharmaceutical decays. Sincethe rate of decay is generally known, one may utilize the rate of decayand the duration of time that has passed from the initial fill time todetermine how much storage time may be needed to sufficiently ensurethat the spent container no longer has a significant amount ofradioactivity associated therewith. This calculation of storage time maybe accomplished manually and/or electronically (e.g., using anappropriate computer interconnected with the reader utilized to read thetag just prior to disposal).

At post processing station 51 within the supplier facility 24 (FIG. 1B),at 808, the used radiopharmaceutical container may undergo suitableprocessing for disposal and, at 810, the associated pig may be cleanedfor reuse. During post processing, any of the computers previouslydescribed can be used to read data from and/or write data to the RFIDtags on the container 20 c, pig 33, carton 34 and/or pallet 67. Suchactivity may be application dependent to fulfill the needs of aparticular supplier, customer, doctor and/or hospital. As shown in FIG.3B, a post processing computer 53 may be connected to an R/W device 55that can be used to read data from and/or write data to the RFID tags 60on one or both the radiopharmaceutical container or the pig. The postprocessing computer 53 may be able (via a communications link 57) toupdate a supplier inventory database 120 tracking radiopharmaceuticalcontainers and pigs within the supplier's facilities. The RFID tags 60on the radiopharmaceutical pigs 33 may be updated or replaced. Further,if desired, data relating to the radiopharmaceutical containers and pigscan be communicated from a supplier computer 116 to computer 79 withinthe hospital 42 via a communications link 118, for example, an Internetconnection, a telephonic connection, or other suitable link.

In methods as contemplated herein, RF tags 60 may be applied to aradioactive pharmaceutical container 20 c that is subsequently placed ina lead lined pig 33. In such a circumstance, the pig limits theusability of the RF tags 60 and may prevent use thereof unless thecontainer 20 c is removed from the pig 33. Therefore, it would be highlydesirable to be able to read data from, and write data to, the RF tag 60on the radiopharmaceutical container 20 c when it is stored inside thepig 33. Such is achieved by an exemplary embodiment of a pig-mountedantenna system shown in FIGS. 20-22.

Referring to FIG. 20, in a first embodiment, a radiopharmaceutical pig33 b has an elongated base 322 and an elongated cap 324. The base 322and cap 324 can be formed in any of a wide variety of shapes and sizes,however, a substantially cylindrical shape is illustrated. The cap 324is joined to the base 322 by a threaded interconnection 325 in a knownmanner. A cap shielding element 326 within the cap 324 and a baseshielding element 328 within the base 322 are used to block radiationthat may be emitted from the radiopharmaceutical within a syringe 20 c.The shielding elements 326, 328 can be formed from any material that iseffective to block radiation, for example, lead, tungsten, a filledpolymer composite material, etc. The cap shielding element 326 forms aprotrusion 329 that overlaps the base shielding element 328 when the cap324 is mounted on the base 322. This overlap of the shields 326, 328facilitates a blockage of radiation through a discontinuity in theshields caused by the cap 324 being separable from the base 322.

The cap 324 further has a cap shell 330 comprised of an outer shellportion 332 and an inner shell portion 334. Similarly, the base 322 hasa cap shell 336 comprised of an outer shell portion 338 and an innershell portion 340. The base and cap shells 328, 330 are made from aplastic material, for example, a polycarbonate resin, etc.

A label 30 is affixed to the radiopharmaceutical syringe 22 c by knownmeans, for example, an adhesive, tape, elastic bands, etc. Indeed, thelabel 30 may be affixed to the radiopharmaceutical syringe 20 c in anyappropriate manner (e.g., so that it is not easily removable). The label30 contains indicia 346 that is in human readable and/or machinereadable form. The label 30 further has an RFID tag 60 that comprises anRFID integrated circuit chip 212 and at least one radio frequencyantenna 210. The radiopharmaceutical syringe 20 c is often manufacturedat a facility independent of the healthcare facility where it is to beused. Therefore, data relating to the radiopharmaceutical syringe 20 cis often collected at the point of its manufacture. Further, additionaldata is often collected at different points in a distribution channel atwhich the radiopharmaceutical pig 33 b containing theradiopharmaceutical syringe 20 c is handled. Data is also collected uponthe radiopharmaceutical syringe 20 c being used and thereafter, upon itsdisposal or cleaning for an authorized reuse. Thus, over the life of theradiopharmaceutical syringe 20 c and associated radiopharmaceutical pig33 b, data that can be written into the RF ID tag 60 at different timesin the life cycle of the syringe 20 c has been previously described.Such data includes but is not limited to the decay factor for aradiopharmaceutical (e.g., half life of pharmaceutical), its prescribedactivity level (curie level of radiation) at injection time, theactivity level at another time (such as filling time), and/or the timeat which the preparing physician or radiopharmacist assumed theradiopharmaceutical would be injected. The activity level is a functionof time due to the short half life of most radiopharmaceuticals, so theactivity level is designed for a specific injection time.

In order to obtain a maximum benefit from the data stored within theRFID tag 60, it is necessary to be able to read the tag when theradiopharmaceutical syringe 20 c is housed within theradiopharmaceutical pig 33 b. In the embodiment of FIG. 20, at least oneradio frequency inner antenna 358 is applied over an inner surface ofthe inner base shell 340; and at least one radio frequency outer antenna364 is applied over an outer surface of the outer base shell 338. A hole360 extends through the inner base shell 340, the base shield 328, andthe outer base shell 338. At least one connecting lead 362, for example,a copper wire lead, extends through the hole 360 and has one endconnected to the inner antenna 358 and an opposite end connected to theouter antenna 364.

The inner antenna 358 is designed to couple with the RFID antenna 210connected to the RFID chip 212. The outer antenna 364 is designed toelectromagnetically couple with a read/write (“R/W”) device 366 in thesame way that the RFID antenna 210 would couple with the R/W device 366.The R/W device 366 is connected to a computer 368 in a known manner. TheRAIN device 366 electromagnetically couples with the RFID antenna 210via the inner and outer antennas 358, 364 respectively. Therefore, anytime the radiopharmaceutical pig 33 b is handled in its life cycle, theR/W device 366 can be used to read information from, and/or writeinformation to, the RFID chip 212 of the RFID tag 60 on theradiopharmaceutical syringe 20 c via an RFID antenna system comprisingthe antennas 210, 358, 362, 364. It should be noted that the antenna maysimply comprise leads of a sufficient length to be used as an RFIDantenna, in which case there may not be a coiled antenna section 364.

Another exemplary embodiment of a radiopharmaceutical pig 33 b andradiopharmaceutical syringe 20 c utilizing the RFID tag 60 is shown inFIG. 21. In this embodiment, inner and outer antennas 358, 364 arelocated on respective inner and outer surfaces 370, 372 of a top of thecap 324. The antennas 358, 364 are electrically connected by at leastone lead 362 extending through a hole 374 in the top of the cap 324. TheR/W device 366 is able to electromagnetically couple with the RFIDantenna 210 via the inner and outer antennas 358, 364 respectively.Therefore, at any time the radiopharmaceutical pig 33 b is handled inits life cycle, the R/W device 366 can be used to read information from,and/or write information to, the RFID chip 212 of the RFID tag 60 on theradiopharmaceutical syringe 20 c via an RFID antenna system comprisingthe antennas 210, 358, 364.

Placing the antennas 358, 362 in the top of the cap 324 has someadvantages. First, the top of the cap 324 often experiences lessradiation exposure than the base shell 336. Further, the cap outersurface 372 often experiences less physical contact than the base outershell 338 during the handling of the radiopharmaceutical pig 33 b; andhence, the outer antenna 362 on the cap outer surface 372 is lesssubject to physical damage.

A further exemplary embodiment of a radiopharmaceutical pig 33 b andradiopharmaceutical syringe 20 c utilizing an RFID tag 60 is shown inFIGS. 22 and 22A. In this embodiment, the RFID tag 60 has an RFID chip212 on a first portion of a label 30 c that is attached to theradiopharmaceutical syringe 20 c in a manner described earlier withrespect to FIG. 20. A second portion of the label 30 d is locatedoutside of the radiopharmaceutical pig 33 b and has at least one RFIDantenna 210 thereon. The RFID chip 212 on the first label portion 30 cis electrically connected to the antenna 210 by at least oneelectrically conductive lead 376 integral with a tether 378. Theconductive lead 376 and tether 378 may be formed from any materials thatprovide the desired electrical and mechanical properties, for example,an insulated or uninsulated copper wire, a copper trace laminated on asubstrate, etc. The threaded connector 325 is designed to provide aclearance for the conductive lead 376 and tether 378, so that the cap324 can be attached and removed from the base 322 without damaging theconductive lead 376 and tether 378. The R/W device 366 is able toelectromagnetically couple with the RFID antenna 210, and the RFIDantenna 210 communicates data to and from the RFID chip 212 via theconductive lead 376. Therefore, at any time the radiopharmaceutical pig33 b is handled in its life cycle, the R/W device 366 can be used toread information from, and/or write information to, the RFID chip 212 ofthe RFID tag 60 on the radiopharmaceutical syringe 20 c via an RFIDantenna system comprising the antenna 210 and conductive lead 376.

In use, upon receiving an order for a radiopharmaceutical, a label 30having an RFID chip 212 and associated antenna 210 is applied to theradiopharmaceutical syringe 20 c, and the radiopharmaceutical syringe 20c can be placed in a radiopharmaceutical pig 33 b. At that time, dataincluding but not limited to the identity of the syringe and pig can bewritten to the RFID tag 60 in a manner previously described with respectto FIGS. 1A and 1B. The radiopharmaceutical syringe 20 c and pig 33 bare then transported to a location where the syringe 20 c is filled witha desired radiopharmaceutical. This location may be at aradiopharmaceutical supplier or a location of a user of theradiopharmaceutical syringe 20 c. In either event, regardless of wherethe radiopharmaceutical syringe 20 c is filled, as previously described,data can be entered into the RFID tag 60 relating to the fillingprocess, the radiopharmaceutical being filled, and the how theradiopharmaceutical is to be used. After being filled, the pig 33 bholding the syringe 20 c filled with the radiopharmaceutical may betransported and stored several times before it is delivered for use in apreparation and/or imaging room. During use, the syringe 20 c is removedfrom the pig 33 b, and the radiopharmaceutical is injected into anexamination subject or patient. After use, the empty syringe 20 c isplaced back in the pig 33 b and returned to the pharmaceutical supplieror other location for proper disposal of the radiopharmaceutical syringe20 c and reconditioning of the radiopharmaceutical pig 33 b for reuse.

Every time the radiopharmaceutical pig 33 b and/or radiopharmaceuticalsyringe 20 c is handled over their respective life cycles, in a manneras previously described, an R/W device 366 can be used to read datafrom, and/or write data to, the RFID tag 60, thereby providing completechronological history of the radiopharmaceutical pig 33 b and syringeradiopharmaceutical 20 c over the respective life cycles. The systemsillustrated in FIGS. 1A, 3A, 1B, 3B have an advantage in that almost anyinformation is able to be transferred between all entities involved in alife cycle of a syringe 20, which is any entity that can communicatewith the communication link 80. Therefore, data available from a websiteon the internet 83 can be utilized during the life cycle of the syringe20. Such internet communications capabilities permits remote service ofa power injector 50, downloading of an injection protocol, communicationwith a remotely located physician, media supplier or other entity ofinterest and other functions.

While the various principles of the invention have been illustrated byway of describing various exemplary embodiments, and while suchembodiments have been described in considerable detail, there is nointention to restrict, or in any way limit, the scope of the appendedclaims to such detail. Additional advantages and modifications willreadily appear to those skilled in the art. For example, in thedescribed embodiments of FIGS. 20-22, an RFID chip 212 may be positionedinside the pig. In some embodiments, the chip 212 may be located outsidethe pig along with an associated antenna, and the chip may be physicallyattached to the syringe 20 c by a string or other attachment so that theradiopharmaceutical syringe 20 c and RFID information therein remainassociated. Alternatively, the pig 33 b may carry an RFID tag andantenna with no mechanical attachment to the syringe, but it may simplybe known that the data therein relates to the syringe that is in thepig.

Further, in the exemplary embodiments shown and described herein, theantenna systems 229 a, 229 b use one, two and three antenna loops;however, in alternative embodiments, any number of antenna loops may beused. The antenna loops may be configured in any shape and be in thesame plane or in different planes. Further, the antenna loops may or maynot be overlapping. In may, however, be preferable that the antennaloops be individually tuned to resonate at a specific frequency used bythe RFID protocol. Further, in the described embodiment, a switchingcircuit 241 b is located on the same PC board 102 as an RF drivercircuit 224 b; however, in alternative embodiments, a switching circuitmay be located on the second PC board 103, be split between the two PCboards 102, 103 or located elsewhere, for example, with the powerinjector as shown in FIG. 17.

In addition, in the described embodiments, the R/W antenna systems 229a, 229 b are applied to a pharmaceutical injection assembly; however, inalternative embodiments, the R/W antenna systems 229 a, 229 b utilizingmultiple nonparallel antennas may be applied to any devices that supporta medical fluid container. Such devices include but are not limited to awarmer oven or warming box, a container filling station, a pig or othernuclear medicine container, a dose calibration station, a handheldpowered medical fluid dispenser, a syringe disposal station, or otherdevice.

The systems of the described embodiments relate to containers of medicalfluids. Two examples described in detail relate to contrast media andrespective syringes and radiopharmaceuticals and respective containers.In alternative embodiments, referring to FIG. 1C, the container may bean IV bag 130 filled with a medical fluid. Tubing 132 from the IV bag130 may interface with an infusion pump 134 so that a flow of medicalfluid from the IV bag 130 may be regulated via use of the pump 134.While one end of the tubing 132 is generally associated with the IV bag130, the other end of the tubing 132 may be connected to a patient in aknown manner. The IV bag 130 may have a label 30 with a data tag 60 aspreviously described herein, for example, an RFID tag. Further, theinfusion pump 134 may be in electrical communication with anelectromagnetic device capable of reading data from and/or writing datato the data tag 60 of the IV bag 130. For example, the electromagneticdevice may be attached to and/or located within the infusion pump 134.As shown in FIG. 3C, the infusion pump 134 may have a control 136connected to the communications link 80 in a manner similar to thatdescribed with respect to the injector control 93 shown in FIGS. 1A and1B. Thus, the systems of FIGS. 1C and 3C may permit activity relating tothe IV bag 130, the medical fluid therein, and/or the infusion pump 134to be tracked and recorded (e.g., over a life cycle of the IV bag 130).

There are many known structures for mounting a syringe to a powerinjector, and the faceplates shown and described herein are only twosuch structures. Other mounting structures may not permit removal fromthe power head. The inventions claimed herein can be applied to powerheads having any type of structure for mounting a syringe thereto. Inthe shown and described embodiment, a heater 106 is mounted on the PCboards 102, 103; however, in alternative embodiments, the heater 106 maynot be used and therefore, deleted from PC boards 102, 103.

When introducing elements of the present invention or variousembodiments thereof, the articles “a”, “an”, “the”, and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including”, and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements. Moreover, the use of “top” and “bottom”, “front” and “rear”,“above” and “below” and variations of these and other terms oforientation is made for convenience, but does not require any particularorientation of the components.

Therefore, the invention, in its broadest aspects, is not limited to thespecific details shown and described herein. Consequently, departuresmay be made from the details described herein without departing from thespirit and scope of the claims, which follow.

1. A medical fluid injection system, comprising: a container havingcontrast media contained therein and an RF data tag attached thereto; apowerhead having the container coupled thereto and operable to controldelivery of the contrast media from the container, the powerheadcomprising: a housing; a motor within the housing; a control circuitwithin the housing to control the motor; an electromagnetic deviceoperable to read data from the RF data tag; and a user interface withinthe housing and accessible to an operator of the powerhead, the userinterface including a display operable to display data, wherein thecontrol circuit includes software instructions which cause the controlcircuit to read data from the RF data tag by the electromagnetic deviceand display the data read from the RF data tag combined with changabledata from another source.
 2. The system of claim 1, wherein the displayis operable to display data indicative of a presence of at least one ofthe container and the RF data tag on the container.
 3. The system ofclaim 1, wherein the display is operable to display the data in responseto user interaction with the display.
 4. The system of claim 1, whereinthe electromagnetic device is operable to write data to the RF data tag.5. The system of claim 1, wherein the display is operable to display thedata read from the RF data tag overlaying other data displayed on thedisplay.
 6. The system of claim 1 wherein the display is configured todisplay data indicative of an amount of the contrast media in thecontainer.
 7. The system of claim 1, wherein the display is operable toprovide an active user interface.
 8. A method of operation for a medicalfluid injection system, the method comprising: coupling a containerhaving contrast media therein with a powerhead of a medical fluidinjection system, the powerhead comprising a housing, a motor, a controlcircuit within the housing to control the motor, and a user interfacewithin the housing that is accessible to an operator of the powerhead,wherein the user interface comprises a display; reading data from an RFdata tag of the container while the container is coupled with thepowerhead; and displaying at least some of the data read from the RFdata tag on the display of the user interface of the powerhead combinedwith changeable data from another source.
 9. The method of claim 8,further comprising: displaying a representation of the container;interrogating the container for the RF data tag; and in response tofinding the RF data tag, indicating a presence of the RF data tag on therepresentation of the container on the display.
 10. The method of claim8, further comprising: writing data to the RF data tag while thecontainer is coupled with the powerhead.
 11. The method of claim 8,wherein the data read from the RF data tag is displayed overlaying otherdata displayed on the display.
 12. The method of claim 8, wherein thedisplaying comprises displaying data indicative of at least one of anamount of the contrast media in the container, an identity of thecontrast media in the container, manufacturing information for thecontrast media in the container, a radioactivity level of a contrastmedia in the container, a use code for the contrast media in thecontainer, configuration information for the injection system, whetheror not the container was previously used with this or another injectionsystem, a lot number of the contrast media in the container, and anexpiration date of the contrast media in the container.
 13. The systemof claim 1, wherein the user interface includes a touch screen.
 14. Themethod of claim 8, wherein the user interface includes a touch screen.15. The method of claim 14, further comprising: accessing the data fromthe RFID data tag by way of manipulating the touch screen.
 16. Thesystem of claim 1, wherein the container comprises a syringe.
 17. Themethod of claim 8, wherein the container comprises a syringe.
 18. Thesystem of claim 1 wherein the display is configured to display dataindicative of an identity of the contrast media in the container. 19.The system of claim 1 wherein the display is configured to display dataindicative of manufacturing information for the contrast media in thecontainer.
 20. The system of claim 1 wherein the display is configuredto display data indicative of a radioactivity level of a contrast mediain the container.
 21. The system of claim 1 wherein the display isconfigured to display data indicative of a use code for the contrastmedia in the container.
 22. The system of claim 1 wherein the display isconfigured to display data indicative of configuration information forthe injection system.
 23. The system of claim 1 wherein the display isconfigured to display data indicative of whether or not the containerwas previously used with this or another injection system.
 24. Thesystem of claim 1 wherein the display is configured to display dataindicative of a lot number of the contrast media in the container. 25.The system of claim 1 wherein the display is configured to display dataindicative of an expiration date of the contrast media in the container.